ABSTRACT:
A novel, simple, precise, accurate and reproducible RP-HPLC method for cleaning validation and assay for simultaneous estimation of perindopril and amlodipine in tablet dosage form has been developed and validated. The chromatographic separation was performed on WATERS SHERISORB CN column (250mm×4.6mm,5µm) in an isocratic mode utilizing di-potassium hydrogen phosphate buffer (pH 6.5 with OPA): methanol: acetonitrile (70:20:10, v/v/v) as mobile phase, at a flow rate of 1.3 ml/min. Detection was carried out at 210 nm. The method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, LOD and LOQ. The developed cleaning validation method was applied for the analysis of marketed formulation of the drugs. The retention times of perindopril and amlodipine were found to be 3.260 and 4.153 min respectively. The method was found to be specific as there was no swab interference. The Beer Lambert’s law was obeyed in the concentration range 0.5-10 µg/ml for both perindopril and amlodipine. The mean % recoveries at 100% level and % RSD were within acceptance limits for both perindopril and amlodipine. The limit of detection (LOD) and limit of quantitation (LOQ) for perindopril and amlodipine were found to be 0.2 µg/ml and 0.5 µg/ml respectively. The method was found to be robust. Assay of marketed tablet formulation gave assay results within acceptable levels.