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.
Highlights
The kinetic spectrophotometric method is an analytical method in which the rate of a reaction is measured and utilized to determine the concentration of drugs [1]
Pitavastatin Calcium (PIT), chemically known as (3R,5S,6E)-7-[2cyclopropyl-4-(4-fluorophenyl) quinolin-3-yl]-3,5-dihydroxyhept-6enoic acid, is a coenzyme A (HMG-CoA) reductase inhibitors that inhibits the synthesis of mevalonate, a rate-limiting step in cholesterol level
Competitive inhibition of HMG-CoA reductase by the statins decreases hepatocyte cholesterol synthesis, which results in increase extraction of LDL-C from the blood and decreases circulating LDL-C concentrations [14]
Summary
The kinetic spectrophotometric method is an analytical method in which the rate of a reaction is measured and utilized to determine the concentration of drugs [1]. The application of kinetic methods of chemical analysis has gained increasing importance because of their high selectivity and sensitivity. In order to determine the amount of substance being analyzed in solution, it is necessary to measure the rate of decrease of increase of substance concentration. 1), is a coenzyme A (HMG-CoA) reductase inhibitors (statins) that inhibits the synthesis of mevalonate, a rate-limiting step in cholesterol level. Competitive inhibition of HMG-CoA reductase by the statins decreases hepatocyte cholesterol synthesis, which results in increase extraction of LDL-C from the blood and decreases circulating LDL-C concentrations [14]
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