Abstract
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.
Highlights
The active form of fenofibrate, a synthetic phenoxy-isobutyric acid derivate having antihyperlipidemic [1] action, is fenofibric acid
APIs of Fenofibric acid, Pitavastatin standards were procured from Glenmark, Mumbai
We present in this article simple, selective, validated and welldefined stability that shows gradient RP-HPLC methodology for the quantitative determination of Fenofibric acid and Pitavastatin
Summary
The active form of fenofibrate, a synthetic phenoxy-isobutyric acid derivate having antihyperlipidemic [1] action, is fenofibric acid. Fenofibric acid is a lipid-lowering [2] drug used to treat severe hypertriglyceridemia [3, 4], primary hyperlipidemia, and mixed dyslipidemia. Pitavastatin (usually as a calcium salt) is a member of the blood cholesterol [12] lowering medication class of statins [13, 14]. It inhibits HMG-CoA reductase [15], the enzyme that catalyses the first step in cholesterol production, like other statins. The aim of the study is to separate the pharma ingredients Fenofibric and Pitavastatin by using RP-HPLC
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