Analytical Method Development and Validation of Ondansetron and Telmisartan in Tablet Dosage Form by RP-UPLC Method
Abstract
The objective of the present analysis was the improvement of easy, exact as well as reproducible and precise verifies reversed phase Liquid Chromatography with High Performance [UPLC] assays for Telmisartan and Ondansetron. The chromatographic splitting up was done on Acuity UPLC BEH C 18 (50×2.1mm and1.7µm) column with gradient elution. The injection amount was 1µl and also the detection was performed at 214 nm by utilizing photo diode array detector. The evolved as well as a validated UPLC way of Telmisartan and Ondansetron in tablet dosage styles based on ICH tips was precise and accurate, therefore it may be utilized for equally evaluation scientific studies of medications. This process demonstrated the repeatability of outcomes with regard to accuracy, scientific studies, robustness, and then program - suitability problems.
Keywords: UPLC, Ondansetron, chromatography, Telmisartan, accuracy, robustness
Keywords:
UPLC, Ondansetron, chromatography, Telmisartan, accuracy, robustnessDOI
https://doi.org/10.22270/jddt.v12i4-S.5548References
Shetgar et al., RP-UPLC method development and validation for simultaneous estimation of Etoricoxib and Thiocolchicoside in tablets. “Journal of Applied Pharmaceutical Science”. 2022; 12 (02):144-151
Gulhane CA, Panchale WA, Manwar JV, Bakal RL. Liquid chromatographic method for simultaneous estimation of Thiocolchicoside and Etoricoxib from tablet formulation. Asian J Pharm Anal, 2021; 11(2):118–20.
Palte D, Kondalkar A. Stability studies in combine dosage form of Etoricoxib and Thiocolchicoside using RP-HPLC. Int J Res Stud Biosci, 2015; 3(9):163–70.
Sujit P, Nitin D. RP-HPLC method for estimation of Etoricoxib and Thiocolchicoside from tablet dosage form. World J Pharm Pharm Sci, 2016; 5(3):1499–505.
Gulhane CA, Panchale WA, Manwar JV, Bakal RL. Liquid chromatographic method for simultaneous estimation of Thiocolchicoside and Etoricoxib from tablet formulation. Asian J Pharm Anal, 2021; 11(2):118–20.
Palte D, Kondalkar A. Stability studies in combine dosage form of Etoricoxib and Thiocolchicoside using RP-HPLC. Int J Res Stud Biosci, 2015; 3(9):163–70.
Sujit P, Nitin D. RP-HPLC method for estimation of Etoricoxib and Thiocolchicoside from tablet dosage form. World J Pharm Pharm Sci, 2016; 5(3):1499–505
Dedania Zarna et al., RP-HPLC Method for Simultaneous Estimation of Omeprazole and Ondansetron in Combined Dosage Forms, Asian J. Research Chem. 2009; 2(2):108-111.
http://en.wikipedia.org/wiki/Zofran
http://pubchem.ncbi.nlm.nih.gov/compound/ondansetron
http://pubchem.ncbi.nlm.nih.gov/compound/telmisartan
http://www.fda.gov/MedWatch/report.htm
ICH (International Conference on Harmonization) – Guidelines Q2B, Validation of Analytical Procedures: Methodology (CPMP/ICH/281/95).
Jawla S et al, 2010, Development and Validation of Simultaneous HPLC method for Estimation of Telmisartan and Ramipril in Pharmaceutical Formulations, International Journal of PharmTech Research, 2010; 2(2):1625-1633.
Joshi A S et al., Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form, International Journal of Industrial Chemistry, 2013; 4(1):1-9.
Kumar A et al, 2012, UPLC: A preeminent technology in pharmaceutical analysis, Drug research, 2012; 6(3):371- 380.
Kumar G. Vijay et al., Validated RP-HPLC Method for the Estimation of Telmisartan in Serum Samples, International Journal of Research in Pharmacy and Chemistry, 2011; 1(3):703-706.
Kumar N, Sangeetha D. and Balakrishna P., Development and validation of UPLC method for the determination of duloxetine hydrochloride residues on pharmaceutical manufacturing equipment surfaces, Pharmaceutical Methods. 2011; 2(3):161-166.
M Santosh Kumar and Jupally Venkateshwar Rao, Development and Validation of a Stability Indicating RP-HPLC method for simultaneous determination of Telmisartan and Amlodipine in combined dosage form, Asian J Pharm Clin Res, 2014; 7: 32-35.
Mushabbar Bhasa MD et al., Method development and validation of ondansetron in bulk and pharmaceutical dosage form by stability indicating RP-HPLC method, International Journal of PharmTech Research, 2013; 5(2):86-98.
Kottai MA et al., Development and Validation of a Reversed Phase HPLC Method for Simultaneous Determination of Amlodipine and Telmisartan in Pharmaceutical Dosage Form, J. Appl. Chem. Res., 2010; 12:43-52.
Ondansetron @ 3Dchem.com
Patel SR. et al., Development and Validation of analytical method for the determination of Rabeprazole and Ondansetron in pharmaceutical dosage form by Reversed-phase HPLC, International Journal of Chem Tech Research, 2010; 2(3):1531-1536.
Poornima A.N et al, 2014, RP-HPLC method development and validation for simultaneous estimation of esomeprazole and ondansetron in combined tablet dosage form, WJPPS, 2014; 4:1041-1051.
Rajitha S. et al., Method Development and Validation of Telmisartan and Amlodipine Besylate by RP-HPLC in Tablet Dosage Form, Int. J. Pharma Sci., 2013; 3(5):365-369.
Reddy M. Kalyan Obula, et al., Method Development and Validation of Rabeprazole in Bulk and Tablet dosage form by RP-HPLC Method, International Journal of ChemTech Research, 2011; 3(3):1580-1588.
Sasidhar RLC et al., Development and Validation of RP - HPLC Method for the Simultaneous Determination Of Hydrochlorothiazide, Amlodipine Besylate and Telmisartan in Bulk and Pharmaceutical Formulation, Oriental Journal of Chemistry, 2014; 30(4):1815-1822.
Rohith T. et al., Development and Validation of UPLC Method for the Determination of Duloxetine Hydrochloride and Its Impurities in Active Pharmaceutical Ingredient, Journal of Analytical and Bioanalytical Techniques, 2015; 6(1):228-234.
Shah K et al., Analytical Method Development and Validation for Simultaneous Estimation of Ondansetron and Dexamethasone in Synthetic Mixture, Journal of Pharmaceutical and Biomedical Sciences, 2014; 4(5):448-458.
Rajeswari R, Jeyaprakash K, Bioactive potential analysis of brown seaweed Sargassum wightii using UV-VIS and FT-IR. Journal of Drug Delivery and Therapeutics 2019; 9(1):150-153
Singh R, HPLC method development and validation- an overview. J Pharm Educ Res. 2013; 4(1):26-33.
Subhashini. E and B. Syama Sundhar, New Analytical Method Development And Validation For The Simultaneous Estimation Of Telmisartan And Hydrochlorothiazide In Bulk And Tablet Dosage Form Using RP-HPLC, Carib.j.SciTech, 2014; 2:519-529.
Padma M, Ganesan S, Jayaseelan T, Azhagumadhavan S, Sasikala P, Senthilkumar S, Mani P, Phytochemical screening and GC–MS analysis of bioactive compounds present in ethanolic leaves extract of Silybum marianum (L)., Journal of drug delivery and therapeutics 2019; 9(1):85-89
Verma V., A review on HPLC and RP-HPLC analysis method, Indian Pharmacology and Pharmacy Research, 2014; 1(1):1-6.
Saminathan J, Vetrichelvan T. Development and Validation of HPTLC method for the simultaneous Estimation of Escitalopram oxalate and Clonazepam in its Formulation. Int J Front Sci Tech. 2014; 2(1):13-23.
Hemalatha P, Ganesh M, Peng MM, et al., Colourimetric estimation of Escitalopram Oxalate in formulation by ion association complex with methyl orange. Asi J Chem. 2013; 25(6):3410-3414.
Samanta T, Dey S, Samal HB, et al., RP-HPLC method for the estimation of Escitalopram in bulk and in dosage forms. Int J Chem Res. 2011; 2(2):11-15.
Bhimanadhuni CN, Garikapati DR, Usha P. Development and validation of an RP-HPLC method for the simultaneous determination of Escitalopram Oxalate and Clonazepam in bulk and its pharmaceutical formulations. Int Cur Pharm J. 2012; 1(8):193-198.
Elham AT, Nahla NS and Shudong W. Micelle Enhanced Fluorimetric And Thin Layer Chromatography Densitometric Methods for the Determination Of (±) Citalopram And Its S – Enantiomer Escitalopram, Anal. Chem Insight, 2009; 4(2):1–9.
Dhaneshwar SR, Mahadik MV and Kulkarni MJ. Column Liquid Chromatography-ultraviolet And Column Liquid Chromatography/Mass Spectrometry Evaluation of Stress Degradation Behavior of Escitalopram Oxalate, J. Asso of Offi Analy Chem International, 2008; 92 (1):138-147.
Zheng H, Yang L and Tang WY. Determination of Plasma Escitalopram With Liquid Chromatography-mass Spectrometry, Nan Fang Yi Ke Da Xue Xue Bao, 2008; 28(11):2044-2046.
Sungthong B, Jac P and Scriba G. Development and validation of a capillary electrophoresis method for the simultaneous determination of impurities of escitalopram including the R-enantiomer, J. of Pharma and Biomed Ana. 2008; 46:959–965.
Soliman SM and Youssef NF. Enantiomeric thin-layer chromatographic assay of escitalopram in presence of “in-process impurities”, J. of Plan Chromatogr. 2011; 24(6):475-481.
Umamaheshwari D, Jayakar B. RP-HPLC method for the simultaneous determination of Etizolam and Propranolol in pure and its tablet dosage form. Int J pharm chem Bio Sci. 2015; 5(1):213-216.
Masaru T, Shibamoto A, Ritsuko W and Sosuke M. Simultaneous Determination of Triazolam, Etizolam And Their Metabolites by High-performance Thin Layer Chromatography, Japanese J. Foren Toxi, 2003; 21(2):150-151.
Masaru T, Hideki S, Tatsuo S and Eisuke T. Simultaneous Determination of Triazolam, Etizolam and Their Metabolites by LC/ESI-TOFMS, Japanese J of Foren Toxi. 2005; 23(2):174-175.
Sakhreliya BD, Trivedi PD, Modi DK. Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Escitalopram oxalate and Etizolam in their Combined Tablet Dosage Form. J Pharma Sci Biosci Res. 2012; 2(5):195-200.
Prasenjit Mondal, Santhosh. B, Sobha Rani Satla, Ramakrishna Raparla. A new validated simultaneous RP- HPLC method for estimation of escitalopram oxalate and etizolam in bulk and table dosage form. Sch Res Lib. 2013; 5(3):26-32.
Kakde RB, Satone D and Bawane N. HPTLC Method for Simultaneous Analysis of Escitalopram Oxalate and Clonazepam In Pharmaceutical Preparations, J. Plana Chromatogr, 2009; 22(6):417–420.
Patel NK, Rana BH, Patel DM, Vyas AJ, Patel AB, Patel AI. Stability Indicating RP-UPLC Method for Simultaneous Estimation of Rabeprazole Sodium and Mosapride Citrate in Tablet Dosage form. Research Journal of Pharmacy and Technology. 2021; 14(9):4535-9.
Published



How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).