Development and validation of reversed phase high-performance liquid chromatography method for estimation of lercanidipine HCl in pure form and from nanosuspension formulation.

AIM Quantitative estimation of lercanidipine HCl in bulk material as well as from nanosuspension formulations via a developed reverse phase HPLC method. MATERIALS AND METHODS Optimized chromatographic condition was used to achieve separation on a Kromasil (100-5c18 250 × 4.6 mm) column using Shimadzu HPLC system. The mobile phase consisted of a mixture of acetate buffer (20 mM pH 4.5) and acetonitrile in the ratio of 10:90, v/v. It is pumped through the chromatographic system at a flow rate of 1 ml/min. The detection was carried out at 240 nm using ultraviolet-visible spectrophotometry detector. The method was validated as per Q2 (R1) guidelines, and suitability of the developed method was established by optimized nanosuspension formulation. RESULTS The method is specific to lercanidipine (RT: 7.7 min), and has ability to resolve the analyte peak from excipient interferences. It is linear (regression coefficient: 0.9993), accurate (average recovery: 100%), and passed all the system suitability requirements. CONCLUSION Developed method was found applicable for evaluation of drug content, content uniformity, and analyzing samples of dissolution studies of nanosuspension.