Analytical Method Development and Validation of Propranolol and Hydrochlorothiazide

Abstract

The active pharmaceutical components of Propranolol and Hydrochlorothiazide in their bulk dosage forms were to be measured using a unique, straightforward, responsive, and stable RP- HPLC method that was being developed and gradually validated. For the quantitative determination of Propranolol and Hydrochlorothiazide, a straightforward, specific, verified, and well-defined stability that exhibits gradient RP-HPLC approach has been developed. The Waters C18 column (150mm×4.6mm, 5mm particle size) was used for the chromatographic method, which involved isocratic elution with a mobile phase made up of orthophosphoric acid (0.1%) and acetonitrile (40:60% v/v). The instrument parameters called for a flow rate of 1 ml/min and a detection wavelength of 265 nm using the UV detector. The chromatographic method was expedited using the impurity-spiked solution. The proposed method's validity was examined in accordance with the international conference on harmonization (ICH) guidelines. The plotted calibration charts had linear regression coefficients of 0.999, indicating that their linearity was within acceptable bounds. The suggested approach is quick, easy, practical, and reasonably priced. It can be used for routine manufacturing sample analysis during stability tests and to confirm the caliber of medication samples during stability studies.