Method Development and Validation of Pitavastatin Calcium and its Degradation Behavior under varied Stress Conditions by UV Spectrophotometric methods

Abstract

UV spectrophotometric methods for the determination of pitavastatin calcium in pure and pharmaceutical dosage forms were developed and validated as per ICH guidelines. The standard pitavastatin calcium solutions were scanned between the ranges of 200-400 nm. The maximum absorbance of pitavastatin calcium in DMF (method A), HCl (method B) and NaOH (method C) was recorded at 266 nm. They obeyed Beers law concentration in the range of 10-45 μg/ml (method A), 0.25-2.0 μg/ml (method B) and 0.25-2.0 μg/ml (method C) with correlation coefficients 0.9996, 0.9998 and 0.9998 respectively. Stability study showed high stability of pitavastatin calcium in acidic, alkaline medium and at high temperature, but undergone degradation in oxidative stress condition. The developed methods were validated for linearity, precision, accuracy, LOD, LOQ, ruggedness, robustness and recovery studies. The proposed methods can be successfully used for the routine quality control analysis of pitavastatin calcium in bulk and commercial pharmaceutical formulations.
 Dhaka Univ. J. Pharm. Sci. 18(2): 159-169, 2019 (December)

A Promising Single Oral Disintegrating Tablet for Co-Delivery of Pitavastatin Calcium and Lornoxicam Using Co-Processed Excipients: Formulation, Characterization and Pharmacokinetic Study

“…11,19 In-vitro Dissolution Study The dissolution study of the PITA-ODTs was performed using a USP dissolution system, Distek (Model 2500i Type II, TCS-0500 Scheduler, New Jersey, USA) at 37 ±0.5 °C and 50 rpm using 100 mL of SSF (pH 6.8) as a dissolution medium. At predetermined time intervals (2,4,6,8, 10, 20 min), 5 mL aliquots were withdrawn and immediately replaced with an equal volume of fresh SSF (pH 6.8) solution kept at the same temperature. The samples were filtered via 0.45-µm membrane filters.…”

“…Pitavastatin calcium (PITA) is a new addition to statins, which is chemically known as monocalcium (3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptanoic acid. 1,2 It has a unique pharmacological effect on the reduction of low-density lipoprotein-cholesterol (LDL-C) and the improvement of high-density lipoprotein-cholesterol (HDL-C) via competitive inhibition of the liver enzyme, 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. 1,3 Nevertheless, the overuse of statin therapy may cause myopathy, which is the most reported side effect of statin.…”

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

“…Literature survey for PST and EZB revealed several methods based on varied techniques like spectrophotometry [14,15], HPLC [16,17], LCMS [18,19], are available for individual drugs, and very few methods are available in combinations which showed a tedious effect on the environment. Upon further considerations, the goal of this work was to conduct a new framework for implementing GAC principles in tandem with AQbD principles.…”

Determination of Pitavastatin Calcium by Analytical Spectrophotometry

“…These include spectrophotometric method, based on ability of potassium permanganate to oxidize Pitavastatin in acidic medium 6 . UV spectrophotometric methods for the determination of Pitavastatin calcium 7,8 , Color reactions for spectrophotometric determination of Pitavastatin calcium 9,10. Spectrofluorometric method is based on measuring the native fluorescence of the drugs at their optimum excitation and emission wavelengths 11 , High performance thin layer chromatography (HPTLC) 12,13 .…”