Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE, CHLORTHALIDONE AND TELMISARTAN IN TABLET DOSAGE FORM

Mauly P. Patel*, Komal P. Patel and Dhaval B. Patel

ABSTRACT

A specific, precise and accurate RP-HPLC method was developed for the separation and quantification of Cilnidipine, Chlorthalidone and Telmisartan in pharmaceutical dosage form. The quantification was carried out using Zorbax Eclipse XDB C8 (150X4.6mm,5 μm) and mobile phase comprised of 0.025M Potassium Dihydrogen Phosphate Buffer(pH-2.5 adjusted with 10%OPA) and ACN in proportion of ratio 75:25 degassed under ultra-sonication. The flow rate was adjusted to 1.0 mL/min and the effluent was monitored at 233 nm using PDA detector. The retention time of Cilnidipine, Chlorthalidone and Telmisartan were about 6.773 min, 3.867min and 2.033 min respectively. The method was validated in terms of linearity, specificity, precision, accuracy, limit of detection and limit of quantization. Linearity of Cilnidipine, Chlorthalidone and Telmisartan were in the range of 5 – 30 μg/mL, 6.25 – 37.5 μg/mL and 20 – 120 μg/mL respectively. The percentage recoveries of three drugs were found to be 100.85±0.74, 99.91±0.65 and 99.68±0.53 for Cilnidipine, Chlorthalidone and Telmisartan respectively from the tablet formulation. The method was found to be precise, accurate and specific during the study. The proposed method enables rapid quantification and simultaneous analysis of drugs from commercial formulations without any excipients interference. The method can be used for routine analysis of marketed products of Cilnidipine, Chlorthalidone and Telmisartan in combined Tablet formulation.

Keywords: Cilnidipine, Chlorthalidone, Telmisartan, Tablet, RP-HPLC.