Abstract

DEVLOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND CHLORTHALIDONE IN ITS BULK AND TABLET DOSAGE FORM USING QUALITY BY DESIGN APPROCH

Pooja Bhagwat Tarakh*, Poonam Vijay Walekar, Prof. Sandeep Adhude and
Prof. Pravin Atmaram Rathod

ABSTRACT

In the present study, a new, sensitive, suitable, simple, precise, and robustreversed-phase high- performance liquid chromatography (RPHPLC)method was developed and validated for the determination ofTelmisartan and Chlorthalidone in bulk drug and tablet formulation.Optimization was done by response surface methodology, applying athree-level Box- Behnken design. Three factors selectedwere Acetonitrileconcentration in the mobile phase, flow rate, and pH. The separationwas carried on an HPLC system containing a UV- detector and InertsilC18 column (150 mm x 4.6; 5μm). The detection was carried outat 218 nm. In the developed RP-HPLC method, 0.1% OPA : Acetonitrile,adjusted to a pH 2.5±0.05 by diluted TEA (55:45 %v/v) wasused as mobile phase, at a flow rate of 1.2 mL/min, the method gavesuitable retention time i.e. 2.011 min for Chlorthalidone and 4.056 forTelmisartan which was optimized withthe help of design expert-13 software. The results ofthe analysis in the method were validated in terms of linearity, accuracy, precision, the limitof detection, the limit of quantification, and robustness. The linearity of the developedmethod was confirmed over the concentration range of 10-50 μg/mL for Chlorthalidone and10-50 μg/mL for Telmisartan, correlation coefficient (r2) of 0.999 for both the drugs. Thepercentage RSD for the precision of the method were found less than 2.0 %. The percent- age recoveries were found to be in the range of 99.25-101.45% for Chlorthalidone and 98.04and 101.36 for Telmisartan. The LOD and LOQ for CHLOR and TEL were found to be 1.88ug/mL and 5.72 ug/mL, 1.82 ug/mL and 5.41 ug/mL respectively. The developed and validatedRP-HPLC method is less time consuming, it can be performed routinely in the industryfor routine quality control/analysis of bulk drug and marketed product of Chlorthalidone andTelmisartan.

Keywords: RP-HPLC, QbD, Telmisartan, Chlorthalidone, Acetonitrile, Development, Validation.