METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATIONSTUDIES OF CILNIDIPINE AND TELMISARTAN BY QBD APPROACH USING RP-HPLC METHOD

Abstract

Several spectrophotometric and HPLC methods have been reported for the determination of Telmisartan and Cilnidipine in drugs and pharmaceutical dosage forms. The present study focuses on optimizing, developing, and validating a sensitive and specific reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of Cilnidipine and Telmisartan in bulk and tablet formulation. Design of Experiments (DoE) was employed to optimize the RP-HPLC method. A forced degradation study was conducted under various stress conditions, including acidic, basic, oxidative (H₂O₂), photolytic, and thermal degradation.

In the developed RP-HPLC method, a mobile phase consisting of Methanol and Water (70:30 %v/v) was utilized at a flow rate of 1.0 ml/min on an HPLC system equipped with a UV detector and HPLC Workstation software. The chromatographic separation was achieved using a Cosmosil C18 column (250 mm x 4.6 mm ID, 5 µm particle size), with detection carried out at 232 nm. The retention times were found to be 4.623 minutes for Telmisartan and 10.379 minutes for Cilnidipine. The robustness values were less than one, indicating method stability.

The method's performance was validated in terms of solution stability, specificity, linearity, accuracy, precision (repeatability and intermediate precision), limit of detection (LOD), limit of quantification (LOQ), and robustness. The sensitivity, accuracy, precision, specificity, and robustness of the developed RP-HPLC method were found to be in accordance with regulatory guidelines.