Analytical Method Development and Validation of RP-HPLC Method for the Simultaneous Determination of Amlodipine Pesylate and CelecoxiP In Pulk And Pharmaceutical Dosage Form

Abstract

Amlodipine besylate and celecoxib is used to treat high blood pressure (hypertension). A survey of literature reveals that only one stability indicating HPLC method has been reported for the simultaneous estimation of amlodipine besylate and celecoxib in their combined dosage form. An attempt was made to develop accurate, precise, sensitive and reproducible RP-HPLC method for the simultaneous estimation of amlodipine besylate and celecoxib in bulk and pharmaceutical dosage form. The method was developed in reverse phase mode using phenomenex C₁₈ column, methanol and water as mobile phase in the ratio of 73:27 (% v/v) at a flow rate of 1.1 ml/min and quantitation was achieved with ultraviolet (UV) detection at 265 nm and the retention time was found to be 5.14 min and 7.12 min for amlodipine besylate and celecoxib respectively. Method validation was carried out according to the ICH guidelines. The linearity was found to be in the range of 1–5 µg/mL and 20-100 µg/mL for Amlodipine besylate and celecoxib respectively. The percentage recovery of Amlodipine besylate and Celecoxib were found to be 98.90 and 99.99% respectively. Precision was done by analysing interday precision, intraday precision and repeatability. The limits of detection for amlodipine besylate and celecoxib were found to be 0.021 and 0.024 µg/mL respectively. The limits of quantification were found to be 0.065 and 0.073  µg/mL for amlodipine besylate and celecoxib respectively.  The parameters checked in system suitability studies are HETP, number of theoretical plates, column efficiency, capacity factor. The HPLC method was found to be specific since there was no co-eluting peak with the drug. Therefore, the combination drug of amlodipine besylate and celecoxib can be routinely used for the quality control analysis without any interaction from their impurities or common excipients.