Development and Validation of Bioanalytical Method for Analysis of Simvastatin
Harshal Garse*, Vilasrao Kadam
Department of Pharmaceutics, Bharati Vidyapeeth’s College of Pharmacy, Sector-8, CBD Belapur, Navi Mumbai-400614, Maharashtra (India).
This work deals with development of a simple, precise, accurate and economical high performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection for the analysis of antihyperlipidemic drug Simvastatin from human plasma. Nicardipine hydrochloride was employed as the internal standard. Liquid-liquid extraction technique with ethyl acetate solvent was used for preparation of biological samples. Analysis was performed on a HiQSil C18HS (250X4.6 mm, 5μm) HPLC column using Acetonitrile: 10 mM Ammonium acetate buffer (pH 5.9) (80:20 v/v) as mobile phase at a flow rate of 1 mL/min. Sample injection was done by means of an auto sampler and detection was carried out using UV detector at a wavelength of 238 nm. A good linearity was found in the concentration range of 100-1000 ng/mL. The developed method was validated according to US-FDA and European Medicines Agency (EMEA) guidelines for linearity, accuracy, precision and stability. The values obtained were found to be within the prescribed limits. The described method can be applied for pharmacokinetic analysis in real clinical samples.