DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ANALYSIS OF LERCANIDIPINE IN BULK DRUG AND MICROEMULSION FORMULATION

Abstract

A simple, sensitive, and stability indicating method is described for the quantitative determination of lercanidipine both in bulk drugs and microemulsions, also in the presence of its degradation products. The method was based on high-performance liquid chromatographic (HPLC) separation of drug from its degradation products. The analysis was carried out on C18 reverse phase (Agilent TC-C18(2) column (250 mm × 4.6 mm I.D., 5-micron particle size)) in isocratic mode at ambient temperature using separation mobile phase, impelled by binary pump, consisting of acetonitrile (ACN) and disodium hydrogen phosphate (Na₂HPO₄) buffer, pH 4 (55:45, v/v volume). Flow rate was 1.0 mL min⁻¹ with an average operating pressure of 140 kg cm⁻² and t_R was found to be 8.3 ± 0.15 min. Quantitation was achieved with UV detection at 240 nm based on peak area with linear calibration curves at concentration range 10–40 µg mL⁻¹. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. The wide linearity range, sensitivity, accuracy, and simple mobile phase imply the method is suitable for routine quantification of lercanidipine in bulk drugs and microemulsion formulation with high precision and accuracy.

Keywords:

• lercanidipine (LER)
• method development
• microemulsion
• reversed phase HPLC
• stress degradation
• validation

Notes

*Mean of five values.

*Mean of six values.