AN IMPROVED CHEMOMETRIC ASSISTED TECHNIQUE WITH QBD APPROACH FOR ESTIMATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE FROM COMBINED FORMULATION

Gurappa Kashinath Dyade*, Samrudhi Sharad Chavan, Pranjali Chandrakant Waghmare, Puja Chatrabhuj Kawade, Dipali Bhimdevrao Taware

ABSTRACT

Various pharmaceutical processes including analytical methods are designed and developed by Quality by design approach. Chemometric based analytical method was developed by using principles of QbD for the estimation of telmisartan (TST) and Hydrochlorothiazide (HCTZ) on the UV-VIS spectrophotometer. Ecological suitable solvent 0.1 N HCl was utilised to make solutions; 271.5 nm and 291 nm was the wavelength for absorbance measurement. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 0-24 mcg/ml. The accuracy was found with SD 1.62621for TST and 1.89292 for HCTZ; and the precision study data % RSD 1.73061 for TST and 0.91855 for HCTZ was found in the acceptable range. The developed method is rigid, robust and efficient for the estimation of TST and HCTZ, from their combined dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.

Keywords: QbD, Telmisartan, Hydrochlorothiazide, ICH, simultaneous equation, chemo metric method.