High performance liquid chromatographic analysis of lercanidipine in human breast milk

Abstract

Abstract: A simple, rapid, precise and accurate isocratic reversed phase HPLC method was developed andvalidated for the determination of lercanidipine hydrochloride in pharmaceutical tablets and spiked human breastmilk. The chromatographic separation was achieved on C18 (250×4.6 mm×5µm) column using a mobile phaseconsisting of acetonitrile and phospate buffer (pH=4) (55:45, v/v) at a flow rate of 1.1 mL/min and UV detectionat 237 nm. The linearity of the proposed method was investigated in the range of 1.0-40 μg/mL (r2=0.9990). Themethod was validated in terms of accuracy, precision, reproducibility, specificity, robustness, and detection andquantification limits, in accordance with ICH guidelines. The proposed method is found as suitable for routinequantification of lercanidipine in human breast milk.