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Abstract

A NEW RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF EZETIMIBE AND SIMVASTATIN IN BULK AS WELL AS IN PHARMACEUTICAL FORMULATION BY USING PDA DETECTOR

Sowjanya Surisetti*, S. Ashutosh Kumar, J. Saravanan, Manidipa Debnath, V. Greeshma, N. Sai Krishna, G. Satya Sri

ABSTRACT

Ezetimibe is a drug that lowers cholesterol. It acts by decreasing cholesterol absorption in the intestine. Ezetimibe decreases cholesterol levels, the results of two major, high-quality clinical trials (in 2008 and 2009) showed that it did not improve clinically significant outcomes, such as major coronary events, and actually made some outcomes, such as artery wall thickness, worse. Ezetimibe actually increased the thickness of artery walls (a measurement of atherosclerosis) and caused more major cardiovascular events. Simvastatin is a hypolipidemic drug used to control elevated cholesterol, or hypercholesterolemia. It is a member of the statin class of pharmaceuticals. Simvastatin is a synthetic derivate of a fermentation product of Aspergillus terreus. This study was designed to develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (HPLC) method for the determination of Ezetimibe and simvastatin in bulk and its tablet dosage forms. The HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 x 150mm, 3.5 m) with a mobile phase composed sodium dihydrogen ortho phosphate [the pH was adjusted to 3.0 by using Orthophosporic Acid] & Acetonitrile in the ratio of 30:70 v/v in isocratic mode at a flow rate of 1.0 ml/min. The run time was maintained 8 mins. The retention times obtained for the drug Ezetimibe was around 2.2mim and for the drug simvastatin was 3.2. The detection was monitored at 242 nm. The calibration curve was linear from 50 to 90μg/ml. The inter-day and intra-day precision was found to be within the specified limits. The proposed method has adequate sensitivity, reproducibility, and specificity for the determination of Ezetimibe and Simvastatin in bulk and its tablet dosage forms. The limit of detection for the drug Ezetimibe and Simvastatin was found to be 0.072μg/ml and 0.12μg/ml solution. The Limit of Quantification for the drug Ezetimibe and Simvastatin was found to be 0.15μg/ml and 0.41μg/ml respectively. The Accuracy recoveries were 98.0-102.0% and reproducibility was found to be satisfactory. The proposed method is simple, fast, accurate, and precise for the quantification of Ezetimibe and Simvastatin in the dosage form, bulk drugs as well as for routine analysis in quality control. The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, Accurate and Precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Overall the proposed method was found to be suitable and accurate for the Quantitative determination in Bulk as well as in Pharmaceutical dosage form.

Keywords: High Performance Liquid Chromatography; Sodium Dihydrogen ortho Phosphate; Acetonitrile; Ezetimibe and Simvastatin.


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