Analytical method development and validation of assay test of pravastatin sodium tablets
A simple, accurate, precise and stability indicating Ultra performance liquid chromatographic method for determination of pravastatin sodium in tablet dosage form. The separation was carried on Acquity UPLC ® HSS C18, 2.1 × 100mm, 1.8µm ID column, with mobile phase comprising of mixture of pH 5.5 buffer: methanol in the ratio of 30 : 70 v/v, as the mobile phase at a flow rate 0.2 ml/min and the detection was carried out using UV-visible detector at 238nm. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness, robustness, filter equivalency, solution stability. The retention time were found to be 1.5 min. Calibration curves were linear with correlation coefficient (r2) 0.999. The Percent assay of Pravastatin sodium tablet was found to be 98.4%. The developed methods were validated as per the ICH guidelines.
Keywords: Pravastatin sodium (PVS), UPLC, Method Validation.
2. Quion, J A., et al, Clinical pharmacokinetics of pravastatin. Clin. Pharm., 1994; 27(2):94-103.
3. Jungnickel, P W., et.al, Pravastatin: a new drug for the treatment of hypercholesterolemia. Clin. Pharmacy, 1992; 11(8): 677-689.
4. Gomes F P., Garcia P L. et al, Development and validation of stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin and rosuvastatin in pharmaceuticals. Anal. Lett., 2009; 42(12):1784-1804.
5. Chaudhari B G., et al, Determination of simvastatin, pravastatin sodium and rosuvastatin calcium in tablet dosage forms by HPTLC. Indian J of Pharm Sci, 2007; 69(1):130-132.
6. Ashour, S., et al, Quantitave determination of pravastatin in pharmaceutical dosage forms by High-Performance Liquid Chromatography with ultraviolet detection. Int J Biomed Sci, 2008; 4(2):135-139.
7. Lennernäs H, Fager G. Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Clin. Pharmacokinet. 1997; 32:403–425.
8. Hatanaka, T. et al, Clinical pharmacokinetics of pravastatin: mechanisms of pharmacokinetic events. Clin. Pharmacokinet. 2000; 39:397–412.
9. Haria M, McTavish D. Pravastatin. A reappraisal of its pharmacological properties and clinical effectiveness in the management of coronary heart disease. Drugs. 1997; 53:299–336.
10. Rang H P, Dale M M, Ritter JN, Flower R J. Rang and Dale’s Pharmacology. 6th ed. Edinburgh: Churchill Livingstone, Elsevier Science Ltd.; 2003.
11. Mahley RW, Bersot T P. Drug therapy for hyper-cholesterolemia and dyslipidemia. In: Hardman JG, Limberd LE, editors. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. New York: The McGraw Hill, Medical Publishing Division; 2007. p. 984-9.
12. Menddham, J., Denney, R., M. J. K., Vogel’s Textbook of Quantitative Chemical Analysis, 6th Edn.; India ; Pearson Education (Singapore) P. Ltd., 2003.
13. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline –Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, London, 2005.
14. “ICH guidelines, validation of analytical procedure: Methodology Q2B”; I.C.H. Harmonized Tripartite Guidelines, 1996.
15. ICH, Q2A “Text on validation of analytical procedures”, Int. Conference of Harmonization, Oct. 1994.
16. ICH, Q3B “Text on validation of analytical procedures”: methodology, Int. Conference of Harmonization, Nov.1996.
17. Dinc, E., Yucesoy, C and Onu, F, J. Phar. Biomed. Anal., 2002, 15, 1091.
18. ICH, 3QB Validation of Analytical Procedures: Methodology, International Conference on Harmonization. November 1996.
19. ICH, Q1A Stability testing of new drug substances and products, in: Proceedings of the international conference on harmonization, Geneva, Switzerland, October, 1993.
20. ICH, Q2B, Harmonised tripartite guideline, Validation of analytical procedure: Methodology, International conference on harmonization, Geneva, Switzerland, 1996.
21. ICH Guidance on analytical method validation, International convention on quality for the pharmaceutical industry, Toronto, Canada, 2002.
22. ICH, Q1B, Stability testing: photostability testing of new drug substances and products. In: International Conference on Harmonization, IFPMA, Geneva, Switzerland, 1996.
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