Method development and validation for simultaneous estimation of telmisartan and hydrochlorothiazide in bulk and pharmaceutical dosage forms by RP-HPLC
Keywords:
Telmisartan, Hydrochlorothiazide, Precision, Accuracy, Linearity, HPLCAbstract
An economic, uncomplicated, selective, detailed, and accurate RP-HPLC procedure for simultaneous quantitative determination of telmisartan and hydrochlorothiazide in combined dosage forms was formulated and validated according to ICH guidelines. The method was developed using Agilent 1200 series HPLC and INERTSIL column C18(150x4.6 ID) 5mm in isocratic mode, with mobile phase comprising of sodium dihydrogen phosphate buffer: acetonitrile (30:70) the flow rate was 1.0 ml/min and the detection was carried at a wavelength of 293nm. The retention time and percentage assay of purity for telmisartan and hydrochlorothiazide was found to be 2.853 min and
4.090 min, 100.43% and 99.40% respectively. The method was successfully validated for accuracy, precision, ruggedness, linearity and range, specificity and robustness in accordance with ICH guidelines. The proposed method was found to be within the acceptance limits indicating that the method is accurate, specific and economical.
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