STABILITY INDICATIVE AND COST EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FENOFIBRIC ACID AND PITAVASTATIN BY USING RP-HPLC
Keywords:Fenofibric acid, Pitavastatin, RP-HPLC, Development, Validation
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Fenofibric acid and Pitavastatin.
Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Fenofibric acid and Pitavastatin. The chromatographic strategy utilized X-bridge phenyl column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (60:40). A flow rate of 1 ml/min and a detector wavelength of 242 nm utilizing the PDA detector were given in the instrumental settings.
Results: Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.
2. Wójcicki J, Pawlik A, Samochowiec L, Kaldo?? Ska M, My?liwiec Z. Clinical evaluation of lecithin as a lipid-lowering agent. Phytotherapy Research 1995; 9(8): 597–599.
3. Blair HA, Dhillon S. Omega-3 carboxylic acids (Epanova): a review of its use in patients with severe hypertriglyceridemia. Am J Cardiovasc Drugs 2014; 14: 393–400.
4. Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of hypertriglyceridemia: an endocrine society clinical practice guideline. J. Clin. Endocrinol. Metab 2012; 97(9): 2969–89.
5. Norata GD, Pirillo A, Ammirati E, Catapano AL. Emerging role of high density lipoproteins as a player in the immune system. Atherosclerosis 2012; 220(1): 11–21.
6. Shah AS, Tan L, Long JL, Davidson WS. Proteomic diversity of high density lipoproteins: our emerging understanding of its importance in lipid transport and beyond. Journal of Lipid Research 2013; 54(10): 2575–85.
7. Gill, Jason; Sara Herd; Natassa Tsetsonis; Adrianne Hardman. Are the reductions in triacylglycerol and insulin levels after exercise related?. Clinical Science 2002; 102(2): 223–231.
8. Zhang J, Herscovitz H. Nascent lipidated apolipoprotein B is transported to the Golgi as an incompletely folded intermediate as probed by its association with network of endoplasmic reticulum molecular chaperones, GRP94, ERp72, BiP, calreticulin, and cyclophilin B. J. Biol. Chem 2003; 278(9): 7459–7468.
9. Peterson MM, Mack JL, Hall PR, Alsup AA, Alexander SM, Sully EK, Sawires YS, Cheung AL, Otto M, Gresham HD. Apolipoprotein B is an innate barrier against invasive Staphylococcus aureus infection. Cell Host & Microbe 2008; 4(6): 507–509.
10. Gremel, Gabriela, Wanders, Alkwin, Cedernaes, Jonathan, Fagerberg, Linn, Hallström, Björn, Edlund, Karolina, Sjöstedt, Evelina, Uhlén, Mathias, Pontén, Fredrik. The human gastrointestinal tract-specific transcriptome and proteome as defined by RNA sequencing and antibody-based profiling. Journal of Gastroenterology 2015; 50(1): 46–57.
11. Lappin, Graham, Rowland, Malcolm, Garner R. The use of isotopes in the determination of absolute bioavailability of drugs in humans. Expert Opinion on Drug Metabolism & Toxicology 2006; 2(3): 419–427.
12. Alenghat FJ, Davis AM. Management of Blood Cholesterol. JAMA 2019; 321(8): 800–801.
13. Kajinami K, Takekoshi N, Saito Y. Pitavastatin: efficacy and safety profiles of a novel synthetic HMG-CoA reductase inhibitor. Cardiovascular Drug Reviews 2003; 21(3): 199–215.
14. Bellosta S, Corsini A. Statin drug interactions and related adverse reactions. Expert Opinion on Drug Safety 2012; 11(6): 933–46.
15. Menzies SA, Volkmar N, van den Boomen DJ, Timms RT, Dickson AS, Nathan JA, Lehner PJ. The sterol-responsive RNF145 E3 ubiquitin ligase mediates the degradation of HMG-CoA reductase together with gp78 and Hrd1 (PDF). eLife 2018; 7.
16. Akioyamen LE, Genest J, Shan SD, Reel RL, Albaum JM, Chu A et al. Estimating the prevalence of heterozygous familial hypercholesterolaemia: a systematic review and meta-analysis. BMJ Open 2017; 7(9): e016461.
17. Van Craeyveld E, Jacobs F, Gordts SC, De Geest B. Gene therapy for familial hypercholesterolemia. Curr Pharm Des 2011; 17(24): 2575–91.
18. Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. The Cochrane Database of Systematic Reviews 2020; 5: CD011737.
19. Sacks FM, Lichtenstein AH, Wu JH, Appel LJ, Creager MA, Kris-Etherton PM, et al. Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Circulation 2017; 136(3): e1–e23.
20. Garrison SR, Dormuth CR, Morrow RL, Carney GA, Khan KM. Nocturnal leg cramps and prescription use that precedes them: a sequence symmetry analysis". Arch. Intern. Med 2012; 172(2): 120–6.
21. Qu H, Guo M, Chai H, Wang WT, Gao ZY, Shi DZ. Effects of Coenzyme Q10 on Statin-Induced Myopathy: An Updated Meta-Analysis of Randomized Controlled Trials. Journal of the American Heart Association 2018; 7(19): e009835.
22. Mukhtar RY, Reid J, Reckless JP. Pitavastatin. International Journal of Clinical Practice 2005; 59(2): 239–52.
23. Kawashiri MA, Nohara A, Tada H, Mori M, Tsuchida M, Katsuda S, et al. Comparison of effects of pitavastatin and atorvastatin on plasma coenzyme Q10 in heterozygous familial hypercholesterolemia: results from a crossover study. Clinical Pharmacology and Therapeutics 2008; 83(5): 731–9.
24. Caprio, Sonia, Pierpont, Bridget, Kursawe, Romy. The adipose tissue expandability hypothesis: a potential mechanism for insulin resistance in obese youth. Hormone Molecular Biology and Clinical Investigation 2018; 33(2).
25. Nakagomi A, Shibui T, Kohashi K, Kosugi M, Kusama Y, Atarashi H, Shimizu W. Differential Effects of Atorvastatin and Pitavastatin on Inflammation, Insulin Resistance, and the Carotid Intima-Media Thickness in Patients with Dyslipidemia. Journal of Atherosclerosis and Thrombosis 2015; 22(11): 1158–71.
26. Villegas R, Xiang Y. B, Elasy T, Xu, W. H, Cai, H, Cai Q, Linton M, Fazio S, Zheng W, Shu X. O. Purine-rich foods, protein intake, and the prevalence of hyperuricemia: The Shanghai Men's Health Study. Nutrition, Metabolism, and Cardiovascular Diseases : NMCD 2011; 22(5): 409–416.
27. Ogata N, Fujimori S, Oka Y, Kaneko K. Effects of three strong statins (atorvastatin, pitavastatin, and rosuvastatin) on serum uric acid levels in dyslipidemic patients. Nucleosides, Nucleotides & Nucleic Acids 2011; 29(4–6): 321–4.
28. Vijayakumari M, Balasekhar reddy Ch. Stability indicating validated hplc method for the determination of zanubrutinib in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res 13: 2020; 159-62.
29. Shivani C.P, Maheshwari D. G, Development and validation of UV spectrometric and HPLC method for estimation of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form. AJPTI 2016; 4: 59-70.
30. Supriya T, Naresh D, Vijaya Kumar G, Haneer MA. Stability indicating RP-HPLC method development and validation for simultaneous estimation of escitalopram and flupentixol pure and marketed formulation. Asian J Pharm Res 2018; 8:4-10.
How to Cite
Copyright (c) 2021 Ramchandran D, ANITHA KETHIPALLI, ANITHA KETHIPALLI, KRISHNAMURTHY MANNAM
This work is licensed under a Creative Commons Attribution 4.0 International License.