VALIDATED KINETIC SPECTROPHOTOMETRIC DETERMINATION OF PITAVASTATIN CALCIUM USING ACIDIC PERMANGANATE OXIDATION

Authors

  • MARWA K. A. L. JAMAL Beirut Arab University, Faculty of Pharmacy, Department of Pharmaceutical Technology

DOI:

https://doi.org/10.22159/ijpps.2020v12i3.35888

Keywords:

Pitavastatin Calcium, Potassium Permanganate, Oxidation, Kinetic methods and Spectrophotometry

Abstract

Objective: Development and validation of a sensitive, indirect spectrophotometric kinetic method, based on oxidation-reduction reaction, using potassium permanganate, for the quantitative assay of pitavastatin calcium, a cardiovascular drug used for the treatment of hyperlipidemia.

Methods: The developed spectrophotometric kinetic method is based on the ability of potassium permanganate to oxidize Pitavastatin, where, the drug solution is treated with a fixed concentration of permanganate in acidic medium, and after a specified time, the unreacted permanganate is measured at 525 nm. All variables affecting the color development have been investigated and the conditions were optimized. Different kinetic methods, including initial rate, rate constant, fixed time and fixed concentration, were applied for the determination Pitavastatin.

Results: During the course of the reaction, the absorbance values, at 525 nm, related to KMnO4, decreased linearly with increasing the concentration of the drug. The reaction rate obeyed was found to be pseudo-first-order and the kinetic method used was the fixed-time method. The assay of PITA in the concentration range of 16-80 μg/ml, using the fixed time method was successfully determined with a correlation coefficient value of 0.9999. The applicability of the developed method was also demonstrated by the determination of pitavastatin in its pure form and in its pharmaceutical formulation, where, the effect of excipients has also been studied and found to have no effect.

Conclusion: The developed indirect spectrophotometric kinetic method, using the fixed time method, was used for the determination of Pitavastatin in pharmaceutical tablets. This method was simple, accurate and easy to apply for routine assay and in quality control laboratories.

Downloads

Download data is not yet available.

References

Iatsimirskii KBK. No Title. Metody Analiza Moscow; 1963.

Yatsimirsku KB. Kinetic methods of analysis international series of monographs in analytical chemistry. 1st Editio. Oxford: Pergamon Press; 1966. p. 35-54.

Anastasia CZ, Constantine GP. Simultaneous determination of iron(II) and iron(III) oxides in geological materials by ion chromatography. Analyst 1990;115:809-12.

Salinas FL, Berzes Nevado JJ, Espinosa M. The solubility of alkali-metal fluorides in non-aqueous solvents with and without crown ethers, as determined by flame emission spectrometry. Talanta 1984;31:325–30.

Sanchiez CP, Albero MI, Garcia SM. Kinetic determination of Hg(II) in different materials, based on its inhibitory effect on a catalysed process. Talanta 1988;35:397–400.

Shantier SW, Gadkarien EA, Ibrahim K, Hagga ME. Kinetic determination of tobramycin in drug formulations. Res J Pharm Biol Chem Sci 2012;3:566–73.

Darwish I, MAS, AL-Arfaj H. Novel selective kinetic spectrophotometric method for determination of norfloxacin in its pharmaceutical formulations. Talanta 2009;78:1383–8.

Rizk M, Belal F, Ibrahim F, Ahmed SM, El-Enany NM. A simple kinetic spectrophotometric method for the determination of oxamniquine in formulations and spiked biological fluids. J Pharm Biomed Anal 2000;23:503-13.

AOM, AAO, ZAT. Kinetic spectrophotometric determination of certain cephalosporins in pharmaceutical formulations. Int J Anal Chem 2009. Doi:10.1155/2009/596379

NR, AKN, HASN. Kinetic spectrophotometric method for the determination of silymarin in pharmaceutical formulations using potassium permanganate as oxidant. Pharmazie 2004;59:112-6.

Niranjani S, Venkatachalam K. Simple titrimetric, spectrophotometric and gravimetric methods for the assay of pitavastatin calcium in a green manner. J Pharm Sci Res 2019;11:1766–74.

Kumar JVS, Prasanthi S, Guravaiah M, Sekaran C bala. Application of potassium permanganate to the spectrophotometric determination of oseltamivir phosphate in bulk and capsules. Asian J Pharm Clin Res 2012;5:18–22.

Yulianita R, Sopyan I, Muchtaridi M. Forced degradation study of statins: a review. Int J Appl Pharm 2018;10:38–42.

O’Neil M, Smith A, Heckelman P. The merck index merck research laboratories. Thirteenth; 2001.

Virupaxappa BS, Shivaprasad KH, Latha MS. Novel spectrophotometric method for the assay of pitavastatin calcium in pharmaceutical formulations. Chem Sin 2011;2:1–5.

M. K. NRP, S. M, S. J. S. B, D. S, R. and Srinivas M. Spectrophotometric determination of 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors in pharmaceutical preparations. Biomed Chromatogr 2006;20:282–93.

Virupaxappa BS, Shivaprasad KH, Latha MS. Novel spectrophotometric method for the assay of pitavastatin calcium in pharmaceutical formulations. Der Chem Sinica 2011;2:1–5.

Yunoos M, Sowjanya M, Sushma B, Kumar KP. A validated simple UV spectrophotometric method for the estimation of pitavastatin in bulk and pharmaceutical dosage form. Asian J Res Chem 2014;7:393–6.

Janagiraman S, Raju T, Giribabu K. Simple titrimetric analysis for determination of pitavastatin calcium in bulk and formulation dosage. Int J Modern Chem 2014;6:18–27.

Sujatha K, Rao JVLNS. A new validated stability-indicating RP-HPLC method for the estimation of pitavastatin in tablet dosage forms. Int J Pharm Pharm Res 2014;3:67–74.

Neelima B, Kumar PR, Bindu VH, Prasad YR. A validated stability-indicating RP-HPLC method for estimation of pitavastatin in bulk and pharmaceutical dosage form. Int J Pharm Sci 2013;3:309–15.

Kumar NS, Nisha N, Nirmal J, Sonali N, Bagyalakshmi J. Pharmaceutical determination of pitavastatin calcium in pharmaceutical dosage forms. Pharm Anal Acta 2011;2:2–5.

Goud ES, Reddy VK, Reddy MNC. Development and validation of a reverse-phase liquid chromatographic method for the determination of related substances of pitavastatin for 2 and 4 mg tablets. Int J Pharm Pharm Sci 2014;6:95–100.

Antony Raj Gomas, Pannala Raghu Ram, Nimmakayala Srinivas, Jadi Sriramulu. Degradation pathway for pitavastatin calcium by validated stability indicating UPLC method. Am J Anal Chem 2010;2:83–90.

Grobelny P, Viola G, Vedaldi D, Dall'Acqua F, Gliszczynska Swigło A, Mielcarek J. Photostability of pitavastatin-a novel HMG-CoA reductase inhibitor. J Pharm Biomed Anal 2009;50:597–601.

Ashwini Ojha, Swati Guttikar, Chintan Vayeda, Harish Padh. Determination of pitavastatin from human plasma using high-performance liquid chromatography with fluorescence detection. Chin J Chromatography 2007;25:715–8.

Tian L, Huang Y, Jia Y, Hua L, Li Y. Development and validation of a liquid chromatography-tandem mass spectrometric assay for pitavastatin and its lactone in human plasma and urine. J Chromatography B 2008;865:127–32.

ICH Harmonized Tripartite guideline, Validation of analytical procedures text and methodology Q2 (R1) Currant step 4 version, Parent guideline dated 27 November (Complementary guideline on Methodology dated 6 incorporated Geneva; 1996. p. 1-13.

Tirumala K, Gautam CHVS, Gangadhar J, Jayajeevitha M, Prakash KV. RP-HPLC assay for estimation of pitavastatin in bulk and pharmaceutical dosage forms. Int J Pharm Sci Nanotechnol 2014;7:2346–9.

JN, Mileer JCM. Statistics and chemometrics for analytical chemistry. 5th ed. London, Pearson Prentice Hall; 2005.

Published

01-03-2020

How to Cite

JAMAL, M. K. A. L. “VALIDATED KINETIC SPECTROPHOTOMETRIC DETERMINATION OF PITAVASTATIN CALCIUM USING ACIDIC PERMANGANATE OXIDATION”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 12, no. 3, Mar. 2020, pp. 28-33, doi:10.22159/ijpps.2020v12i3.35888.

Issue

Section

Original Article(s)