FORCED DEGRADATION STUDY OF STATINS: A REVIEW

Authors

  • Rini Yulianita Department of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia 45363
  • Iyan Sopyan Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia 45363
  • Muchtaridi Muchtaridi Department of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia 45363

DOI:

https://doi.org/10.22159/ijap.2018v10i6.29086

Keywords:

Forced degradation study, Stress testing, Drugs stability, Statins

Abstract

Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies. Statins, a class of lipid-lowering medications, are the most widely prescribed drugs and an example of an unstable drug. Statins are susceptible to hydrolysis in the presence of high temperatures and humidity. Therefore, the review discusses various studies of forced degradation studies in six statins drug (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) to describe the drug's intrinsic stability thus it can assist the selection of formulations and packaging as well as proper storage conditions.

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References

Singh S, Junwal M, Modhe G, Kurmi M, Parashar N, Sidduri P. Forced degradation studies to assess the stability of drugs and products. Trends Anal Chem 2013;49:1-41.

ICH Expert Working Group. ICH guideline Q1A (R2): stability testing of new drug substances and products. Int Conf Harmon; 2003. p. 24.

Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-a review. J Pharm Anal 2014;4:159-65.

Jenke DR. Chromatographic method validation: a review of current practices and procedures. II. Guidelines for primary validation parameters. J Liq Chromatogr 1996;19:737–57.

Ferenczi Fodor K, Vegh Z, Renger B. Impurity profiling of pharmaceuticals by thin-layer chromatography. J Chromatogr A 2011;1218:2722-31.

Bakshi M, Singh S. Development of validated stability-indicating assay methods–critical review. J Pharm Biomed Anal 2002;28:1011–40.

Davidson MH. Rosuvastatin: a highly efficacious statin for the treatment of dyslipidemia. Expert Opin Investig Drugs 2002;11:125-41.

Petyaev IM. Improvement of hepatic bioavailability as a new step for the future of statin. Arch Med Sci 2015;11:406-10.

Schachter M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam Clin Pharmacol 2004;19:117-25.

Sanjaymitra PVSS, Ganesh GNK. Dissolution and solubility enhancement strategies: current and novel prospectives. J Crit Rev 2018;5:1-10.

Gupta D, Mandowara V, Patel S, Shelat P. Improvement of efficacy and safety profile of simvastatin in comparison to the reference product (Zocor tablets) using nanoparticulate formulation approach. Int J Curr Pharm Res 2016;8:39-47.

Reddy KVR, Nagabhushanam MV. The role of the needle in the formulation of pH-sensitive swellable microbeads prepared with hydrophilic polymers for atorvastatin and their characterization studies. Int J Appl Pharm 2017;9:20-30.

Dayyih WAABU, Mallah EM, Al-Ani IH, Arafat TA. Liquorice beverage effect on the pharmacokinetic parameters of atorvastatin, simvastatin, and lovastatin by liquid chromatography-mass spectroscopy/mass spectroscopy. Asian J Pharm Clin Res 2016;9:174-9.

Alvarez Lueje A, Valenzuela C, Squella JA, Nunez-Vergara LJ. Stability study of simvastatin under hydrolytic conditions assessed by liquid chromatography. J AOAC Int 2005;88:1631-6.

Jemal M, Zheng O, Powell ML. Direct-injection LC–MS–MS method for high-throughput simultaneous quantitation of simvastatin and simvastatin acid in human plasma. J Pharm Biomed Anal 2000;23:323-40.

Shah RP, Kumar V, Singh S. Liquid chromatography/mass spectrometric studies on atorvastatin and its stress degradation products. Rapid Commun Mass Spectrom 2008;22:613-22.

Kadav AA, Vora DN. Stability-indicating UPLC method for simultaneous determination of atorvastatin, fenofibrate, and their degradation products in tablets. J Pharm Biomed Anal 2008;48:120-6.

Vora DN, Kadav AA. Validated ultra HPLC method for the simultaneous determination of atorvastatin, aspirin, and their degradation products in capsules. J Liq Chromatogr Relat Technol 2008;31:2821-37.

Kumar KK, Rao CK. A validated stability indicating RP-UPLC method for atorvastatin calcium. Am J Anal Chem 2012;3:392-9.

Vukkum P, Abu JMOB, Uralikrishna RM. Stress degradation behavior of atorvastatin calcium and development of a suitable stability-indicating LC method for the determination of atorvastatin, its related impurities, and its degradation products. Sci Pharm 2013;81:93-114.

Gite S, Patravale V. Validation of RP-HPLC method and stress degradation for the combination of metformin HCl, atorvastatin calcium, and glimepiride: application to nanoparticles. J Chromatogr Sci 2015;53:1654-62.

Singh S, Dahiya R. Stability-indicating RP-HPLC method for estimation of atorvastatin calcium in the solid dosage form. Bull Pharm Res 2014;4:9-13.

Sathiyasundar KVR. New stability indicating assay method by liquid chromatographic separation of aspirin, atorvastatin, and clopidogrel in the pharmaceutical dosage form. Indo Am J Pharm Res 2014;4:5919-27.

Oliveira MA, Yoshida MI, Belinelo VJ, Valotto RS. Degradation kinetics of atorvastatin under stress conditions and chemical analysis by HPLC. 2013;18:1447-56.

Lakka NS, Goswami N, Balakrisna VSP. Development and validation of a stability-indicating RP-HPLC for the simultaneous determination of atorvastatin calcium and simvastatin in pharmaceutical solid dosage forms. Int J Res Pharm Sci 2011;2:608-15.

Aiyalu R, Mani K. HPTLC method development, validation, and stress degradation studies for atorvastatin and ezetimibe in the multicomponent tablet dosage form. Med Chem Res 2012;21:1297-301.

Goel A, Baboota S, Sahni JK. Development and validation of stability-indicating assay method by UPLC for a fixed dose combination of atorvastatin and ezetimibe. J Chromatogr Sci 2013;51:222-8.

S Naidu P, S Durga, R Baby Nalanda, Bolla N, Atla SR. A validated stability indicating RP-HPLC method for the simultaneous determination of atorvastatin calcium and ezetimibe hydrochloride in bulk and tablet dosage form. Int J Pharm Pharm Sci 2016;8:370-7.

Akabari AH, Suhagia BN, Saralai MG, Sutariya VA. Development and validation of stability indicating RP-HPLC method for estimation of fluvastatin sodium in bulk and capsule dosage form. Eurasian J Anal Chem 2017;12:87-105.

Gomes FP, Garcia PL, Alves JMP, Singh AK, Kedor-Hackmann ERM, Santoro MIRM. Development and validation of stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin, and rosuvastatin in pharmaceuticals. Anal Lett 2009;42:1784-804.

Aglawe KV, Kharat UP, Dongaonkar CC, Chavan VA. Development and validation of stability indicating UV spectrophotometric method for the determination of pitavastatin calcium. World J Pharm Pharm Sci 2016;5:1773-87.

Akabari AH, Shah DR, Shah SA, Suhagia BN. Kinetic determinations of pitavastatin calcium by a stability indicating HPTLC method. J Liq Chromatogr Relat Technol 2015;38:521-31.

Damle MC, Polawar AR. Stability-indicating HPTLC method for the estimation of pitavastatin calcium in the presence of acid-induced degradation product. Int J ChemTech Res 2014;6:2824-33.

HJ Panchal BNS. Stability-indicating liquid chromatographic method for analysis of pitavastatin calcium in tablet dosage forms. Acta Chromatogr 2011;23:81-94.

Sujatha K, Seshagiri Rao JVLN. A new validated stability-indicating RP-HPLC method for the estimation of pitavastatin in tablet dosage forms. Int J Pharm Anal Res 2014;3:67-73.

Onal A, Sagirli O. Development of a selective LC method for the determination of pravastatin sodium. Chromatographia 2006;64:157-62.

Athota RV, Jagarlapudi SK, Singampalli MR. Stability indicating HPLC method for the simultaneous quantification of aspirin and pravastatin in bulk and tablets: method development and validation. J Appl Pharm Sci 2017;7:48-56.

A Ahmad, BP Panda, Mujeeb M. A validated stability-indicating method for simultaneous analysis of mevastatin and pravastatin in fermentation broth during bioconversion by Actinomadura macra. Acta Chromatogr 2011;23:121-31.

Reddy GR, Reddy PR, Jyothi PS. Development of a stability-indicating stereoselective method for quantification of the enantiomer in the drug substance and pharmaceutical dosage form of rosuvastatin calcium by an enhanced approach. Sci Pharm 2015;83:279-96.

Venkat G, Reddy R, Reddy BV, Haque SW, Gautam HD, Kumar P. Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms. Quim Nov 2011;34:250-5.

Mostafa NM, Badawey AM, Lamie NT, El-Aleem EBA. Selective chromatographic methods for the determination of rosuvastatin calcium in the presence of its acid degradation. J Liq Chromatogr Relat Technol 2014;37:2182-96.

Badawy AMRM, Mostafa NM, El ABD, Abd AB, Aleem EL, Lamie NT. Stability­indicating PLS and PCR chemometric methods for the determination of rosuvastatin in presence of its two oxidative degradation products. Int J Pharm Pharm Sci 2011;3:232-7.

Trivedi HK, Patel MC. Development and validation of a stability-indicating RP-UPLC method for determination of rosuvastatin and related substances in the pharmaceutical dosage form. Sci Pharm 2012;80:393-406.

Shah RP, Sahu A, Singh S. LC-MS/TOF, LC-MS, on-line H/D exchange and LC-NMR studies on rosuvastatin degradation and in silico determination of toxicity of its degradation products: a comprehensive approach during drug development. Anal Bioanal Chem 2013;405:3215-31.

Ashfaq M, Akhtar T, Mustafa G, Danish M, Naeem S, Nazar MF. Simultaneous estimation of rosuvastatin and amlodipine in pharmaceutical formulations using stability indicating HPLC method. Brazilian J Pharm Sci 2014;50:629-36.

Mukthinuthalapati MA, Bukkapatnam V, Pavan S, Bandaru K. Stability indicating liquid chromatographic method for the simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical formulations. Adv Pharm Bull 2014;4:405-11.

Belal F, Ibrahim F, Khedr A, Elawady T. Stability indicating TLC method for the determination of rosuvastatin and identification of some degradation products using electrospray ionization mass spectrometry. J Liq Chromatogr Relat Technol 2014;37:1114-32.

Kapuganti ANK, Gandhi BM, Raju VB, Sumanth KS, Kagitapurapu VK, Srinivas K, et al. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of ramipril, aspirin, and simvastatin in bulk and pharmaceutical dosage form. Asian J Biomed Pharm Sci 2016;6:14-20.

El Karbane M, Azougagh M, Al Kamarany MA, Bouchafra H, Cherrah Y, Bouklouze A. Development and validation of a reversed-phase HPLC method for simultaneous analysis of butylhydroxyanisol, simvastatin, and its impurities in tablet dosage forms. Ann Pharm Fr 2014:72:244-55.

Kumar P, Chakraborthy GS. Stability indicating RP-HPLC method development for determination of simvastatin in dosage forms. World J Pharm Sci 2014;3:1189-205.

Rao KLN, Krishnaiah C, Reddy KP. Stability-indicating liquid chromatographic method for the simultaneous determination of ascorbic acid, citric acid, butylated hydroxyanisole, simvastatin, and related compounds in the pharmaceutical solid dosage form. Int J Anal Pharm Biomed Sci 2014;3:1-10.

Devu S, Gupta A, Srinivas KS, Gupta RS, Semwal VP. Chromatography development and validation of stability indicating RP-UPLC method for simultaneous determination in fixed dose combination of ezetimibe and simvastatin. J Chromat Separation Techniq 2012;3:1-7.

Gomes FP, Garcia PL, Alves JMP, Singh AK, Kedor-Hackmann ERM, Santoro MIRM. UV-derivative spectrophotometric and stability-indicating high-performance liquid chromatographic methods for determination of simvastatin in tablets. Latt Am J Pharm 2009;28:261-9.

Silva TD, Oliveira MA, Oliveira RB De, Vianna-Soares CD. Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin, and simvastatin. J Chromatogr Sci 2012;50:831-8.

Ghodke SS. Stability indicating RP-HPLC method for simvastatin and sitaglipin phosphate with degradation studies in marketed pharmaceutical hypo-cholesterol and antidiabetic tablets. Int J Pharm Chem Biol Sci 2018;8:99-109.

Chavhan V, Ghante M. Stability indicating UV spectrophotometric method development and validation of simvastatin in bulk and tablet dosage form. J Appl Pharm 2014;6:235-46.

Sawant S, Ghante M. A validated stability indicating RP-HPLC method for simvastatin, identification and characterization of forced degradation products of simvastatin using LC-ESI-MS/MS. Adv Anal Chem 2015;5:8-16.

Malenovic A, Jancic-Stojanovic B, Ivanovic D, Medenica M. Forced degradation studies of simvastatin using microemulsion liquid chromatography. J Liq Chromatogr Relat Technol 2010;33:536-47.

Nalaiya J, Sagineedu SRAO, Rajasingam R, Kassim Z, Pichika MRAO. A stability-indicating RP-HPLC method for simultaneous determination of simvastatin and niacin in a combined dosage form. Int J Pharm Pharm Sci 2015;7:262-8.

Published

07-11-2018

How to Cite

Yulianita, R., Sopyan, I., & Muchtaridi, M. (2018). FORCED DEGRADATION STUDY OF STATINS: A REVIEW. International Journal of Applied Pharmaceutics, 10(6), 38–42. https://doi.org/10.22159/ijap.2018v10i6.29086

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