Development and Validation of RP-HPLC Method for Simulataneous Estimation of Lercanidipine HCl and Atenolol in Pharmaceutical Formulations

Abstract

A simple, precise and RP-HPLC (reverse phase – high performance liquid chromatographic) method was developed and validated for the simultaneous determination of lercanidipine HCl (LDPH) and atenolol (AT) in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on an Phenomenex Luna® C18 column with a particle size 5 μm, length 250 mm and internal diameter (i.d.) 4.6 mm with isocratic flow. The mobile phase at a flow rate of 1 mL/min consisted of 10 mM potassium dihydrogen phosphate (pH adjusted to 3.1 with 0.1 M ortho-phosphoric acid) and acetonitrile (65:35; v/v). A linear response was observed over the concentration range 2–18 μg/mL of LDPH and the concentration range 10–90 μg/mL of AT. Limit of detection and limit of quantitation for LDPH were 0.5 and 1.5 μg/mL, respectively and for AT were 1 and 3 μg/mL, respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for system suitability, specificity, linearity, accuracy, precision and robustness. The analysis concluded that the method was selective for simultaneous estimation of LDPH and AT.