Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Analysis of Simvastatin using a Simple and Fast High Performance Liquid Chromatography-Ultra Violet Method: Development, Validation and Application in Solubility Studies

Abubakar Munir, Mahmood Ahmad , Muhammad Zubair Malik, Muhammad Usman Minhas

Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine,The Islamia University of Bahawalpur-63100, Punjab, Pakistan;

For correspondence:- Mahmood Ahmad Email: ma786786@yahoo.com Tel:+92629255565

Received: 27 October 2013 Accepted: 18 December 2013 Published: 25 January 2014

Citation: Munir A, Ahmad M, Malik MZ, Minhas MU. Analysis of Simvastatin using a Simple and Fast High Performance Liquid Chromatography-Ultra Violet Method: Development, Validation and Application in Solubility Studies. Trop J Pharm Res 2014; 13(1):135-139 doi: 10.4314/tjpr.v13i1.19

© 2014 The authors.
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Abstract

Purpose: To develop and validate an accurate, rapid and reproducible reversed-phase high performance liquid chromatography (RP-HPLC) analytical method for the lipid lowering drug, simvastatin, and to apply the developed method to study the solubility of the drug in various oils and surfactants.

Methods: Isocratic RP-HPLC system with a UV-vis detector, and a column with dimensions 4.6 mm x 150 mm and 5µ particle size, was employed. The mobile phase consisted of methanol and 0.01M KH₂PO₄phosphate buffer (80:20) at pH 5.5 adjusted with phosphoric acid (2M) and pumped at a flow rate of 1 ml/min_.Validation parameters, viz, limit of detection (LOD), limit of quantification (LOQ) linearity, accuracy, precision, and sensitivity, were established. Solubility study was performed in various oils and surfactants at 25 °C and the developed HPLC method was applied to analyze all samples.

Results: The developed HPLC method showed good linearity (R² = 0.9958 ± 0.0040. The intra- and inter-day % accuracy was more than 98 %. LOQ and LOQ were 0.160 and 0.484 μg/ml respectively. Simvastatin showed the highest solubility in sesame oil (15 mg/ml) and in Tween 80 (11 mg/ml) at 25 ^oC.

Conclusion: An accurate, rapid and robust HPLC-UV method has been developed, validated and applied successfully to determine the solubility of simvastatin in oils.

Keywords: Simvastatin, Validation, Solubility, Sesame oil, Tween 80