masters in analysis

Do power point presentation of 20 slides on the article given below as pdf. Article: Development and Validation of Rapid RP-HPLC Method for determination of Deferasirox in Bulk and Tablet Dosage Forms.

See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/361268930
Development and Validation of Rapid RP-HPLC Method for determination of
Deferasirox in Bulk and Tablet Dosage Forms
Article in Asian Journal of Pharmaceutical Analysis · May 2022
DOI: 10.52711/2231-5675.2022.00013
CITATIONS
READS
6
171
3 authors:
Santhosh Kumar Ettaboina
Komalatha Nakkala
Aurex laboratories LLC
Institute of Chemical Technology, Mumbai
20 PUBLICATIONS 170 CITATIONS
14 PUBLICATIONS 40 CITATIONS
SEE PROFILE
SEE PROFILE
Nayana Chathalingath
Kongunadu Arts and Science College
5 PUBLICATIONS 6 CITATIONS
SEE PROFILE
Some of the authors of this publication are also working on these related projects:
SYNTHESIS AND EVALUTION OF NEW TACRINE DERIVATIVES AS ANTI-ALZHEIMER’S AGENTS View project
ISOLATION OF STARCH FROM CURCUMA LONGA L. AND ITS CHARACTERIZATION View project
All content following this page was uploaded by Santhosh Kumar Ettaboina on 15 June 2022.
The user has requested enhancement of the downloaded file.
Asian Journal of Pharmaceutical Analysis. 12(2): April – June, 2022
ISSN
2231–5667 (Print)
2231–5675 (Online)
DOI: 10.52711/2231-5675.2022.00013
Vol. 12 | Issue-02|
April – June| 2022
Available online at
www.anvpublication.org
www.asianpharmaonline.org
Asian Journal of Pharmaceutical Analysis
Home page www. ajpaonline.com
RESEARCH ARTICLE
Development and Validation of Rapid RP-HPLC Method for determination
of Deferasirox in Bulk and Tablet Dosage Forms
Santhosh Kumar Ettaboina1*, Komalatha Nakkala2, Nayana Chathalingath3
1
Quality Control, Aurex Laboratories LLC, East Windsor, New Jersey, 08520, USA.
2
Department of Pharmaceutical Sciences and Technology,
Institute of Chemical Technology, Mumbai, Maharashtra, India, 400019.
3
PG and Research Department of Biotechnology, Kongunadu Arts and Science College,
Coimbatore, Tamilnadu, India, 641029.
*Corresponding Author E-mail: santhosh.ettaboina22@gmail.com
ABSTRACT:
The reverse phase high performance liquid chromatographic method has been developed for the estimation of
Deferasirox in bulk and in tablet dosage form. Further optimized HPLC method was validated as per the current
ICH guidelines. The experiment was conducted on a Inertsil ODS-3V C18, 150mm length, 4.6mm ID, and 5µm
particle size column using the chromatographic separation was done with 60:40 v/v ratio of Acetonitrile and
Buffer (0.05% Orthophosphoric Acid) as the mobile phase at a flow rate of 1.5mL min-1, and detection of
component was made at 250nm. The HPLC method was accurate, with linearity ranging from 10.8 to 162µg/mL
of Deferasirox, the correlation coeffient >0.999. The method was exposed to a high accuracy of more than 97%.
The results disclose the successful applicability of the current process for the estimation of Deferasirox from its
drug substance and marketed formulation, which can be consciously inferred to assess the other formulation
systems. The developed method was validated in terms of linearity, accuracy, precision, LOD, LOQ, robustness
& ruggedness. The proposed method can be helpful in Quality control laboratories for the determination of
Deferasirox in the pharmaceutical dosage form.
KEYWORDS: Deferasirox, Validation, High Performance of Liquid Chromatography.
INTRODUCTION:
The Antidote class includes Deferasirox (DFS) it’s
chemically known as 4-[3, 5-bis (2-hydroxyphenyl)-1H1, 2, 4-triazol-1-yl]-benzoic acid. DFS is an iron
chelator that can be swallowed by mouth. The main
application of DFS reduce severe iron overload in
patients who need long-term blood exchange for
disorders like beta-thalassemia and other severe
anemias.
Received on 01.12.2021
Modified on 05.02.2022
Accepted on 09.04.2022 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Ana. 2022; 12(2):73-77.
DOI: 10.52711/2231-5675.2022.00013
DFS is an iron (as Fe3+) selective orally active chelator.
It’s a tridentate ligand that complex with iron exceptional
affinity in a 2:1 ratio. Despite the fact that DFS has a low
affinity for zinc and copper, there are varied declines in
serum concentrations of these trace metals following
DFS administration. These declines aren’t known to have
any therapeutic impact. DFS is fairly soluble in
Dimethylformamide, Dimethyl sulfoxide, and slightly
soluble in methanol, practically insoluble in water. DFS
is a powder that is white to slightly yellow in colour.
DFS has molecular formula C21H15N3O4, and its mass is
373.4g/mole. DFS finished products have different types
of inactive ingredients. The structures of DFS are shown
in (figure 1).
73
Asian Journal of Pharmaceutical Analysis. 12(2): April – June, 2022
Few LC approaches have been published in human
plasma determination by LC1, cardiac iron overload in thalassemia, blood2, calcium and argon were involved in
an iron evaluation by ICP-MS3, biological fluids/drug
product determination by sensitized fluorescence4,5,
Pharmacokinetics, distribution of drug, metabolic
pathway, and eliminationiron chelation in animal
models6, few were published in LC chromatography7-12,
17-20
, iron overload and chelation13, Electrocatalytic
oxidation14, and capillary zone electrophoresis15. few
were published in other LC chromatography21-40.
Standard Preparation:
To acquire a concentration of 108µg/mL, the DFS
standard was prepared in the diluent (the diluent was
prepared by mixing water and acetonitrile in a 50:50 v/v
ratio). Representative chromatograms of dilute standard
preparation were presented in (figure 2). (Table 1) shows
the system suitability results and evaluation.
HO
N
N
OH
N
O
Figure 2. Chromatogram of Standard
OH
Figure 1. Chemical structure of Deferasirox
MATERIAL AND METHODS:
Chemicals and Reagents:
DFS (potency-100.0%) was procured from Glen mark
Life sciences, Gujarat, India.VWR International, and
LLC provided the AR grade Orthophosphoric acid. JT
Baker provided an HPLC grade of Acetonitrile with a
purity certificate of 99.9%. For the experimental analysis
high quality double distilled water (Milli-Q) was used
(Total Organic Carbon – TOC 500ppb, pH 5.0-7.0,
Conductivity 1.2 s/cm)
Table 1. System suitability evaluation
Parameters
Deferasirox
Retention Time(min)
3.653
USP Tailing factor
1.1
USP Plate count
3686
% RSD
0.2
Acceptance criteria
±10%
NMT 2.0
NLT 3000
NMT 2.0
Preparations of Sample:
Accurately Weigh and transfer 360mg of crushed tablet
powder (equal 180mg DFS in DFS tablets) to a 50mL
volumetric flask, and add diluent about 35mL,
afterwards sonicate it for 30 minutes with intermediate
shaking, allow to stand at room temperature before
diluting with diluent to volume, and thoroughly mix.
Instrumentation and Software:
It isa HPLC system with an Alliance e2695 elution Centrifuge a portion of the solution for 10 minutes at
module, water software, auto-injector, sample storage 3000rpm.
heat controller column was used in this work. Build 3471
Pipette 3mL test stock supernatant solution in 100 mL
SPs of Empower 3 Software The following signal output
volumetric flask, diluted to volume with diluent, and
was recorded after installation: DB ID: 2639633283,
thoroughly mixed.
Feature Release 3. The Inertsil ODS-3V C18 (150 x 4.6
mm), 5m LC column was made by GL Sciences Inc. An
Method development and optimization:
analytical balance model CP225D (made by Sartorius), a
Analytical method development is a procedure of
top load balance model GP5202 (produced by Sartorius),
proving that the developed chromatography method is
a sonicator (manufactured by LIFECARE), and a
appropriate for its intended use in the improvement and
thermal oven were also used in this experiment (made by
manufacturing of the pharmaceutical drug substance and
NEWTRONIC).
drug product.
Chromatographic conditions:
The chemical structure and functional groups of DFS, as
A mobile phase of 60:40 v/v Acetonitrile and buffer
well as component solubility, were used to develop
(0.05% Orthophosphoric acid in water) was used to
analytical methodologies. The acidic component pka of
produce chromatographic separation at a flow rate of 1.5
DFS is the most powerful (pka 4.55). The structural
-1
mL min . The LC column utilized was an Inertsil ODSpolarity of the component was the starting point for
3V C18 150mm length, 4.6mm ID, and 5µm particle size
HPLC technique development. The completion of any
at a 10µL injection volume. The temperature of the
analytical process is impossible without the use of a
column and sample is kept at 25°C. The PDA and UV
detector. The majority of organic/drug compounds have
detectors were used to identify and quantify the DFS at
UV–vis absorption and are aromatic or unsaturated in
250nm.
74
Asian Journal of Pharmaceutical Analysis. 12(2): April – June, 2022
nature. When it comes to quantifying and characterizing
molecules and their impurities, this is advantageous. The
compound’s absorbance maxima will be measured using
a either UV–visible spectrophotometer or diode array
detector (DAD) in HPLC. The detection was done at the
same wavelength as the DFS’s UV absorbance maxima,
which are at 250nm.
For stationary phase optimization, many types of
columns were thoroughly examined, including Inertsil
ODS-3V C18, (150*4.6mm), 5µm, Phenomenex kinetex
C18 (4.6*150mm), Spherisorb 80Ao C18, (4.6*250mm),
and Symmetry C18, 250mm x 3.0mm, 5.0µm. Different
individual and combinations of solvents such as water,
acetonitrile, methanol, and buffer solutions were
investigated for analyte separation using the abovementioned columns. The buffer and its efficiency have a
big role in peak symmetry and separation. A range of
organic and inorganic buffers are used to produce the
desired separation. To optimize the chromatographic
peak shape of the chemical, 0.05 percent ortho
phosphoric acid was used. DFS is soluble in CH3OH and
a combination of CH3CN and H2O. With 60:40 v/v
Acetonitrile and buffer ratios, the peak forms and
symmetry of DFS were good (0.05 percent ortho
phosphoric acid into water). A series of method
development tests were carried out by changing
conditions of chromatography those including method
flow rate (1.0-2.0 mL min-1) and the temperature of
column (between 30-40°C) to determine the peak shape
and symmetry of the compound As a result, the Inertsil
ODS-3V C18 (150 x 4.6 mm), 5µm column became the
column of choice for this mixture since it gave the most
optimal unambiguous separation of DFS in a relatively
short run time. The target compound’s peak shape was
poor in other columns. Other tests found that employing
the Phenomenex kinetex C18 (4.6*150 mm), Spherisorb
80AoC18 (4.6*250 mm), and Symmetry C18, 250 mm x
3.0 mm, 5.0µm, resulted in significant peak tailing.
Using an isocratic method with a constant flow rate (1.5
mL/min) column, the method was found to have
appropriate peak symmetry and reasonable retention
durations based on the overall optimizations. The
temperature of the sample is kept constant at 25°C.
Placebo solutions. This means that the excipients
employed in the formulation have no effect on the DFS
content of DFS tablets. Representative chromatograms
of blank were presented in (figure 3).
Figure 3. Chromatogram of Blank
Limit of Quantification and Limit of Detection:
To establish the LOD and LOQ of DFS was verified by
the slop method. The LOD &LOQ were calculated by
using the below following formula. The method
validation results are shown in (Table 2).
3.3 X SD of Y-intercept
LOD = ––––––––––––––––––––––––
Slope of a calibration curve
10 X SD of Y-intercept
LOQ = ––––––––––––––––––––––––
Slope of a calibration curve
Linearity:
As per current ICH guidelines, the linearity was tested.
The linearity of detector response was verified by
preparing the individual seven concentrations ranging
from 10% to 150% of the standard concentration. In the
diluent, the linearity solutions were created. The linearity
curve was calculated by injecting each concentration
level of the sample into the HPLC and measuring the
value. The calibration curve was drawn between peak
areas versus the concentration of samples. The linear
regression equations were found to be satisfactory. The
linearity of the approach is indicated by the regression
coefficient value R2 = 0.999, as seen in (figure 4). The
method validation results are shown in (Table 2).
METHOD VALIDATION:
The approach was validated using ICH Q2 (R1)
guidelines from the International Conference on
Harmonization16.
Specificity:
The research was undertaken to determine the
involvement of blank and placebo. According to the test
technique, the assay was done twice on placebo, with
each dose matching to the mass of the placebo in a
fraction of the test preparation. There were no peaks at
the RT of DFS peak on chromatograms of Blank and Figure 4. Linearity Curve for Deferasirox
75
Asian Journal of Pharmaceutical Analysis. 12(2): April – June, 2022
Precision:
A homogeneous test of a single batch was evaluated six
times for method precision. The results determine
whether a method produces consistent results for a single
batch. Six samples were prepared in the same way using
DFS samples, and six samples were prepared the next
day to test the method’s inter-day precision. The
accuracy of the procedure was determined by calculating
the % Relative Standard Deviation (RSD). The summary
findings are shown in (Table 2).
CONCLUSION:
To determine deferasirox in bulk and tablet dosage form,
an accurate, sensitive, and precise RP-HPLC method
with PDA detection was developed and validated in
accordance with ICH guidelines. For Deferasirox, the
suggested method is extremely fast, with a total
analytical run time of less than 5 minutes. Routine
quality control analysis can also be easily changed using
this procedure.
CONFLICT OF INTEREST:
Table 2. Method validation results
Parameters
Deferasirox
Linearity (10-150%)
Range (µg mL-1)
10.8-162
Slope
49434.212
Intercept
-2440.971
Correlation Coefficient
1.000
STYX SD
6312.013
LOD (µgmL-1)
0.421
LOQ (µgmL-1)
1.277
Accuracy(a) ( percent of Recovery)
50% Mean ± SD
100.5±0.54
100% Mean ± SD
99.1±0.98
150% Mean ± SD
100.2±1.22
Precision (b)(%RSD)
Repeatability
1.2
Intermediate precision
1.5
(a)
Each concentration level is average of three determinations
(b)
Percent RSD is six determinations of each component.
The authors have declared no conflicts of interest.
ACKNOWLEDGEMENT:
There was no funding from any of the organizations.
Thank you to the Aurex Laboratories LLC. Management
for agreeing to publication.
REFERENCES:
1.
Accuracy:
Accuracy was established to determine drug extraction
capability diluent at different concentrations, and the
results were within the acceptable range. The present
improved approach’s recovery illustrates how close the
method is to actual theoretical values. The recovery of
the samples was exhibited with three concentration
levels in this HPLC procedure (50 percent, 100 percent,
and 150 percent). API+ placebo was used to perform the
recovery, which was then injected into the HPLC
(triplicate). For each level, the percent recovery was
computed. The findings are summarized in (Table 2).
Robustness:
To demonstrate the robustness of the method, the
chromatographic conditions were purposefully modified,
and Tailing factor (2.0) and theoretical plate counts
(>3000) were validated as system suitability
requirements. Based on the results, the optimal process
approach proved to be robust, even when the parameters
were changed.
Filter validation and solution stability of the sample:
To evaluate the filter’s effect on the sample, two different
types of 0.45m filters were used (Nylon and PVDF).
When compared to the centrifuged sample, there were no
significant differences in the concentrations of both
types of filtered samples. Sample and standard solution
was stable for up to 72 h on the bench top.
Chauzit. Emmanuelle. Bouchet. Stephane. Micheau. Marguerite.
Mahon. Francois Xavier. Moore. Nicholas. Titier. Karine.
Molimard and Mathieu. A method to measure deferasirox in
plasma using HPLC coupled with ms/ms detection and its
potential application. Therapeutic Drug Monitoring. 2010; 32: 476
– 481.
2. Dudley J. Pennell. John B. Porter. Maria DC. Amal El-Beshlawy.
Lee LC. Yesim A. Mohsen SE. Pranee Sutcharitchan. Chi-Kong
Li9. Hishamshah I. Vip Viprakasit. Efficacy of deferasirox in
reducing and preventing cardiac iron overload in β-thalassemia.
Blood. 2010; 115(12): 2364-2371.
3. Marta S. Yolanda M. Carmen C. Elimination of calcium and argon
interferences in iron determination by ICP-MS using
Desferrioxamine chelating agent immobilized in sol–gel and cold
plasma conditions. Journal of Analytical Atomic Spectrometry.
2003; 18: 1103-1108.
4. Manzoori JL. Jouyban A. Amjadi M. Panahi – Azar V. Tamizi E.
Vaez – Gharamaleki J. Terbium. sensitized fluorescence method
for the determination of deferasirox in biological fluids and tablet
formulation. The Journal of Biological and Chemical
Luminescence. 2010.
5. Jamshid L. Manzoori1. Abolghasem J. Mohammad A.
VahidPanahi- Azar. Elnaz Tamizi. Jalil V. Gharamaleki. Terbium
sensitized fluorescence method for the determination of
deferasirox in biological fluids and tablet formulation. The journal
of biological and chemical luminescence. 2010; 11: 160.
6. Bruin GJM. Faller T. Wiegand H. Schweitzer A. Nick H.
Schneider J. Boernsen KO. Waldmeier F. Pharmacokinetics,
distribution, metabolism, and excretion of deferasirox and its iron
complex in rats. Drug MetabDispos. 2008; 36:2523–2253.
7. Chakravarthy VK. Gowrisankar D. LC determination of
Deferasirox in pharmaceutical formulation. Journal of Global
Trends in Pharmaceutical sciences. 2010; 1: 37- 45.
8. Ravi K. Surendranath K. Radhakrishnanand P. Satish J.
Satyanarayana P. A stability indicating LC method for deferasirox
in bulk drugs and pharmaceutical dosage forms. Chromatographia.
2010; 72: 441–446.
9. Desai NC. Senta RD. Simultaneous Rp-HPLC determination of
salicylamide, salicylic acid and deferasirox in the bulk API
dosages forms. Journal of Taibah University for Science. 2015;
9(2): 245-251. DOI: 10.1016/j.jtusci.2014.11.006.
10. Sampath S. Swetha R. Method development and validation for
determination of impurities in deferasirox by RP-HPLC technique.
Journal o f Drug Delivery & Therapeutics. 2012; 2(3): 148-152.
11. Singh S. Mohammed N. Ackerman R. Porter JB. Hide RC.
Quantification of Desferrioxamine and its iron chelating
metabolites by high-performance liquid chromatography and
simultaneous ultravioletvisible/radioactive detection. Analytical
76
Asian Journal of Pharmaceutical Analysis. 12(2): April – June, 2022
Biochemistry. 1992; 203(1): 116-120.
12. Carmen camera. A High-Performance Liquid Chromatographic
Method for the Measurement of Deferoxamine in Body Fluids.
Therapeutic Drug Monitoring. 1989; 11.
13. Choudhry VP. Naithani R. Current status of iron overload and
chelation with deferasirox Indian Journal of Pediatrics. 2007; 74
(8): 759–64.
14. Hajjizadeh M. Jabbari A. Heli H. Moosavi Movahedi AA. Shafiee
A. Karimiand K. Electrocatalytic oxidation and determination of
deferasirox and deferiprone, Analytical Biochemistry. 2019;
373(2):337-348.
15. Ana Valeria. Colnaghi Simionato. Marcelo DC. Emanuel C.
Characterization of metal-deferoxamine complexes by continuous
variation method: A new approach using capillary zone
electrophoresis. Micro chemical Journal. 2006; 82(2): 214-219.
16. ICH Guideline Q2A, Text on validation of analytical procedures,
in: International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use,
1994, http://www.ich.org (November 2012).
17. Katakam LNR. Dongala T. Ettaboina SK. Novel stability
indicating UHPLC method development and validation for
simultaneous quantification of hydrocortisone acetate, pramoxine
hydrochloride, potassium sorbate and sorbic acid in topical cream
formulation,
Talanta
Open.
2020;
1(),
100004–.
doi:10.1016/j.talo.2020.100004
18. Raveendra Babu G. Srinivasa Rao J. Suresh kumar K. Jayachandra
Reddy P. Stability Indicating Liquid Chromatographic Method for
Aripiprazole, Asian Journal of Pharmaceutical Analysis. 2011;
1(1): 03-07.
19. Sharmin Reza Chowdhury. Mahfuza Maleque. Mahbubul Hoque
Shihan. Development and Validation of a Simple RP-HPLC
Method for Determination of Caffeine in Pharmaceutical Dosage
Forms. Asian Journal of Pharmaceutical Analysis. 2012; (1): 0104.
20. Dongala T. Katari NK. Ettaboina SK. Krishnan A. Tambuwala
MM. Dua K. (2021). In vitro Dissolution Profile at Different
Biological pH Conditions of Hydroxychloroquine Sulfate Tablets
Is Available for the Treatment of COVID-19, Frontiers in
Molecular
Biosciences.
2021;
7:613393.
doi:
10.3389/fmolb.2020.613393
21. Manoranjan Sabat. Sharada Nalla. Venkateswarlu Goli. Sravan
Prasad Macherla. Praveena Kumari Matta. Madhu Chandaka S. A
New Analytical Method Development and Validation for
Estimation of Ciprofloxacin in Bulk and Pharmaceutical Dosage
Form, Asian Journal of Pharmaceutical Analysis. 2012; 2(4):116117.
22. Ettaboina SK. Katakam LNR. Dongala T. Development and
Validation of a Stability-Indicating RP-HPLC Method for the
Determination of Erythromycin Related Impurities in Topical
Dosage Form. Pharmceutical Chemistry Journal (2022).
https://doi.org/10.1007/s11094-022-02610-5
23. Thangabalan B. Salomi M. Sunitha N. Manohar Babu S.
Development of validated RP-HPLC method for the estimation of
Itraconazole in pure and pharmaceutical dosage form, Asian
Journal of Pharmaceutical Analysis. 2013; 3(4): 119-123.
24. Katakam LNR. Ettaboina SK. Dongala T. A simple and rapid
HPLC method for determination of parabens and their degradation
products in pharmaceutical dosage forms, Biomedical
Chromatography. 2021; 35(10). doi:10.1002/bmc.5152
25. Gandla. Kumara Swamy N. Ravindra S. Sowmya. A New RPHPLC Method Development and Validation for the Simultaneous
Estimation of Amlodipine and Valsartan in Tablet Dosage Forms,
Asian Journal of Pharmaceutical Analysis. 2014; 4(3):103-107.
26. Macha B. Nakkala K. Garige AK. Akkinepally RR. Synthesis and
Evalution of New Tacrine Derivatives As Anti- Alzheimer’ S
Agents, 2018; vol. 8, no. 1, pp. 590–597.
27. Govinda Rao Kamala. Sowjanya Vadrevu. Malipeddi Haripriya.
Method Development and Validation for Simultaneous Estimation
of Omeprazole and Domperidone by RP-HPLC, Asian Journal of
Pharmaceutical Analysis. 2015; 5(4): 195-205.
28. Katakam LNR. Dongala T. Ettaboina SK. Quality by design with
design of experiments approach for development of a
stability‐indicating LC method for enzalutamide and its impurities
in soft gel dosage formulation, Biomedical Chromatography. 2021;
35(5). doi:10.1002/bmc.5062
29. Sridevi Ranjitha Karanam V. Reena Jyothi Swarupa. Stability
Indicating Analytical Method Development and Validation for
Simultaneous Estimation of Valsartan and Hydrochlorothiazide in
Tablet Dosage Form, Asian Journal of Pharmaceutical Analysis.
2016; 6(1) 7-14.
30. Katakam LNR. Ettaboina SK. Marisetti VM. Development and
validation of LC–MS method for the determination of
heptaethylene glycol monomethyl ether in benzonatate bulk drugs,
Biomedical
Chromatography.
(2021);
35(7).
doi:10.1002/bmc.5096
31. Sushil D. Patil. Sunil V. Amurutkar CD. Upasani. Development
and Validation of Stability Indicating RP-HPLC Method for
Empagliflozin, Asian Journal of Pharmaceutical Analysis. 2016;
6(4): 201-206. doi: 10.5958/2231-5675.2016.00030.2
32. Kirthi A. Shanmugam R. Mohana Lakshmi S. Ashok Kumar CK.
Padmini K. Shanti Prathyusha M. Shilpa V. Analytical Method
Development and Validation of a Stability-indicating RP-HPLC
Method for the Analysis of Danazol in Pharmaceutical Dosage
Form, Asian Journal of Pharmaceutical Analysis. 2016; 6(4): 227234.
33. Yenda P. Katari NK. Dongala T. Vyas G. Katakam LNR.
Ettaboina SK. A simple isocratic LC method for quantification of
trace-level inorganic degradation impurities (ferricyanide,
ferrocyanide, nitrite, and nitrate) in sodium nitroprusside injection
and robustness by quality using design approach, Biomedical
Chromatography, 2021; e5269. https://doi.org/10.1002/bmc.5269
34. Yesha K. Patel MN. Noolvi. Hasumati Raj. Meghna P. Patel.
Development and validation of stability indicating reverse phase
high performance liquid chromatographic method for estimation of
Donepezil HCl from bulk drug, Asian Journal of Pharmaceutical
Research. 2015; 5(2): 96-101.
35. Ettaboina SK. Nakkala K. Development and Validation of New
Analytical Methods for the Simultaneous Estimation of
Levamisole and Albendazole in Bulk and Tablet Dosage Form by
RP-HPLC, Journal of Pharmaceutical Analytics and Insights.
2021; 3(1), dx.doi.org/10.16966/2471-8122.117
36. Muchakayala SK. Katari NK. Dongala T. Marisetti VM. Vyas G.
Vegesna RVK. Eco-friendly and green chromatographic method
for the simultaneous determination of chlorocresol and
betamethasone dipropionate in topical formulations using Box–
Behnken design, Journal of the Iranian Chemical Society. 2021.
https://doi.org/10.1007/s13738-021-02388-5
37. Muchakayala SK. Pavithra K. Katari NK. Marisetti VM. Dongala
T. Vegesna RVK. Development and validation of a RP-UPLC
method for the determination of betamethasone dipropionate
impurities in topical formulations using a multivariate central
composite design. Analytical Methods. 2021; 13(33): 3705-3723.
doi: 10.1039/d1ay01096d.
38. Ettaboina SK. Nakkala K. Laddha KS. A mini review on SARSCovid-19-2 Omicron Variant (B.1.1.529). Scimedical journal.
2021; 3(4):399-406. DOI: 10.28991/SciMedJ-2021-0304-10
39. Leela Prasad K. Naresh Kumar K. Surekha Ch.Christian A.
Sandoval, Siva Krishna M, Naresh Konduru. A Quality by Design
and green LC technique for the determination of mast cell
stabilizer and histamine receptor antagonist (Olopatadine HCl) in
multiple formulations. Biomedical chromatography. 2022; e5359.
doi: 10.1002/bmc.5359
40. Leela Prasad K. Naresh Kumar K. Christian A. Sandoval. Siva
Krishna M.Vijay Kumar R. Unique green chromatography method
for the determination of serotonin receptor antagonist
(Ondansetron hydrochloride) related substances in a liquid
formulation, robustness by quality by design-based design of
experiments approach. Journal of Separation Science. 2022 Mar
13. doi: 10.1002/jssc.202100979.
77
View publication stats