STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROSUVASTATIN CALCIUM IN PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Objective: The present work was focused on the development and validation of the reversed-phase high-performance liquid chromatography (RP-HPLC) method, which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin calcium in bulk and tablet formulation.
Methods: The separation was attained on reversed-phase Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5μ) employing buffer, which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid) and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min. and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of rosuvastatin calcium was found to be 2.844 min.
Results: The linearity of the method was demonstrated in the concentration range of 6-16 µg/ml for rosuvastatin calcium with a correlation coefficient (r2) of 0.9999. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12-101.37% for rosuvastatin calcium. The assay of marketed tablet formulations was found to be 98.99%.
Conclusion: The developed RP-HPLC technique was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and will be used for regular quality control of rosuvastatin calcium in bulk and tablet formulations.
2. The United States Pharmacopeia 29; National Formulary 24, U. S. Pharmacopeal Convention; 2007. p. 1280.
3. Rajput P, Shah DB, Maheshwari DG. A review on the chromatographic method for the estimation of rosuvastatin calcium. Int J Res Pharm Pharm Sci 2018;3:28-31.
4. Kumar TR, Shitut NR, Kumar PK. Determination of rosuvastatin in rat plasma by HPLC: validation and its application to pharmacokinetic studies. Biomed Chromatogr 2006;20:881‐7.
5. Hassouna ME, Salem HO. Stability indicating a new RP-HPLC method for the determination of rosuvastatin calcium in pure and tablets dosage forms. Int J Appl Pharm Biol Res 2017;2:11-27.
6. Sirisha Mulukuri NV, Srinivasarao T, Raveendra BG. New RP-HPLC method development and validation for the estimation of rosuvastatin calcium in bulk drugs and formulations. J Pharm Res 2017;11:257-60.
7. Sailaja B, Sravan Kumari K. Stability-indicating method development and validation for the estimation of rosuvastatin calcium in bulk and tablet formulation by reverse-phase high-performance liquid chromatography. Asian J Pharm Clin Res 2019;12:251-6.
8. Hasumati AR, Rajput SJ, Dave JB, Patel CN. Development and validation of two chromatographic stability-indicating methods for the determination of rosuvastatin in pure from and pharmaceutical preparation. Int J Chem Tech Res 2009;1:677-89.
9. Harshal Kanubhai Trivedi, Mukesh C Patel. Development and validation of a stability-indicating RP-UPLC method for the determination of rosuvastatin and related substances in the pharmaceutical dosage form. Sci Pharm 2012;80:393-406.
10. Singh SS, Sharma K, Patel H, Jain M, Shah H, Gupta S. Estimation of rosuvastatin in human plasma by HPLC tandem mass spectroscopic method and its application to a bioequivalence study. J Braz Chem Soc 2005;16:944-50.
11. Dujuan Z, Jing Z, Xiaoyan L, Chunmin W, Rui Z, Haojing S, et al. Validated LCMS/MS method for the determination of rosuvastatin in human plasma: application to a bioequivalence study in Chinese volunteers. Pharmacol Pharm 2011;2:341-6.
12. Bahrami G, Mohammadi B, Mirzaeei S, Kiani A. Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection. J Chromatography B 2005;826:41-5.
13. Sailaja B, Sravan Kumari K. Stability-indicating method development and validation for the estimation of rosuvastatin calcium in bulk and tablet formulation by reverse-phase high-performance liquid chromatography. Asian J Pharm Clin Res 2019;12:251-6.
14. Damle MC, Waghmare SS, Sinha P. Development and validation of stability-indicating HPTLC method for determination of apixaban as bulk drug. Int J Pharm Pharm Sci 2019;11:37-42.
15. Pathan M, Kshirsagar A. Development of validated stability-indicating method by RP-HPLC for simultaneous estimation of meropenem and vaborbactam in bulk and pharmaceutical formulation. Int J Pharm Pharm Sci 2019;11:102-8.
16. RR, J, Jerin James. A validated RP-HPLC method for simultaneous estimation of pyrantel pamoate and praziquantel in the bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci 2019;11:62-7.
17. Malak Y, Al-Bathish, Azza A Gazy, Marwa K, El-Jamal. RP-HPLC and chemometric methods for the determination of two anti-diabetic mixtures; metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide in their pharmaceutical formulation. Int J Pharm Pharm Sci 2020;12:83-94.
18. Aher SS, Saudagar RB, Kothari H. Development and validation of RP-HPLC method for simultaneous estimation of azilsartan medoxomil and chlorthalidone in bulk and tablet dosage form. Int J Curr Pharm Res 2018;10:21-4.
19. Choppella V, Badipati S, Gonthina H, Chukka VK. Stability indicating method development and validation for simultaneous quantification of sorafenib and regorafenib drug substances by using RP-UPLC. Int J Curr Pharm Res 2020;12:56-62.
20. Chengalva P, Kuchana M. Stability indicating UPLC method for simultaneous determination of phenylephrine hydrochloride, chlorpheniramine maleate, paracetamol, guaiphenesin and bromhexine hydrochloride in bulk and pharmaceutical formulation. Int J Appl Pharm 2019;11:284-92.
21. Kuchana M, Kandukuru C, Chengalva P. Development and validation of RP-HPLC method for simultaneous estimation of ciprofloxacin and fluocinolone acetonide in bulk and pharmaceutical dosage form. Int J Appl Pharm 2020;12:134-8.
22. ICH, Q1A. Stability testing of new drug substances and products. In: Proceedings of the International Conference on Harmonisation, Geneva, October; 1993.
23. https://www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. [Last accessed on 01 Apr 2020].
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