Lovastatin

Lovastatin belongs to the class of cholesterol lowering drugs and is the first clinically used statin. It is available as conventional and extended release tablets, but its low aqueous solubility finally escorts it to low oral bioavailability (less than 5 %). Therefore, improvement in aqueous solubility of Lovastatin is the foremost aim. In the present work Self-nanoemulsifying drug delivery systems (SNEDDS) of Lovastatin is being formulated to increase the water solubility. Lovastatin SNEDDS was formulated with various oils, surfactants and co-surfactants and tested for its maximum solubility and drug release. The optimized Lovastatin SNEDDS formulation (F8) has a composition of Acrysol EL 135 as oil phase, Lauro glycol 90 and Capmul MCM as surfactant and co-surfactant respectively. Formulation F8 was found to be best formulation based on evaluation parameters. No drug precipitation or phase separation was observed in the optimized formulation. The particle size of the optimized formulation was found to be 4.9 nm & Z-Average of 71.5 nm indicating all the particles were in the nanometer range. The zeta potential of the optimized SNEDDS formulation was found to be -13.7 mV which comply with the requirement of the zeta potential for stability. The current investigation of nano emulsion may serve as a promising approach for the formulation development of poorly soluble drug Lovastatin, which has undoubtedly proved the potential effectiveness of SNEDDS for formulating Lovastatin with improved solubility and dissolution. Key words: Lovastatin, SNEDDS, Statin, Lauro Glycol 90, Solubility  

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.