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DOE-Based Stability Indicating RP-HPLC Method for Determination of Lacidipine in Niosomal Gel in Rat: Pharmacokinetic Determination

Mohd Qumbar, Ameeduzzafar, Javed Ali, Syed Sarim Imam, Mohd Fazil and Asgar Ali

Lacidipine (LAC) is a calcium channel blocker used in treatment of hypertension. In this study high performance
liquid chromatography method (HPLC) is applied to the determination of LAC in rat plasma. The design of experiment
used 3- factor 3- level Box Behnken Design for optimization of mobile phase condition. The effluent was monitored
by UV detector at 240 nm, at a flow rate of 1.0 mL/min using amlodipine as internal standard. A linear calibration
curve very well fits our data from 20-1200 ng/mL with limit of detection (LOD) quantitation (LOQ) 1.490 and 4.848
ng mL-1 respectively. The method was found to be linear, precise and accurate. Analytes were stable under various
conditions (during freeze-thaw, at room temperature, and under deep freeze conditions). The pharmacokinetic study
was performed after application of LAC niosomal transgel in rats and results showed enhance bioavailability by 2.57
fold as compared to oral formulation.