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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 KH2PO4 phosphate 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 (R 2 = 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 o C. Conclusion: An accurate, rapid and robust HPLC-UV method has been developed, validated and applied successfully to determine the solubility of simvastatin in oils.

tropical journal of pharmaceutical research

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