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

作者：Munir Abubakar; Ahmad Mahmood^*; Malik Muhammad Zubair; Minhas Muhammad Usman

来源：Tropical Journal of Pharmaceutical Research, 2014, 13(1): 135-139.

DOI：10.4314/tjpr.v13i1.19

• Simvastatin
• Validation
• Solubility
• Sesame oil
• Tween 80

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 5 mu 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 degrees 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 mu g/ml respectively. Simvastatin showed the highest solubility in sesame oil (15 mg/ml) and in Tween 80 (11 mg/ml) at 25 degrees 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.

• 出版日期2014-1