Stability Indicating RP- HPLC Method for the Determination of Niacin and Lovastatin In Bulk Drug and Tablet Formulation

摘要

ABSTRACT A new simple, rapid, precise, accurate and specific stability indicating method has been developed for the simultaneous estimation of Niacin (NIA) and Lovastatin (LOVA) in tablet dosage form. A chromatographic column used for separation was (250*4.6mm i.d., 5 mm) C18 (Hyperchrome ODS-BP).The mobile phase was 0.02M Disodium hydrogen Phosphate buffer:Acetonitrile (75:25, pH-5) and UV detection of effluent at 237nm.The flow rate was 1ml/min. The retention times of Niacin and Lovastatin were 3.29 min and 4.75 min, respectively. The range of Linearity for Niacin and Lovastatin were 125-325μg/ml and 5-25 μg/ml respectively. The recoveries of Niacin and Lovastatin were found to be in the range of 99.91-100.42 % and 100.03-100.41% respectively. The optimized RP-HPLC method proved to be specific, accurate and robust for the estimation of Niacin and Lovastatin in tablet dosage form. Stability testing study includes the acid hydrolysis, base hydrolysis, oxidation, thermal degradation, and photolysis. Keywords: Niacin, Lovastatin, RP-HPLC Method