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Development and Validation of Stability-Indicating RP-HPLC Method for Estimation of Proguanil Hydrochloride in Tablet Dosage Form

Nandini R. Pai and Seema S. Sawant

A rapid RP-HPLC1 method was developed for determination of Proguanil hydrochloride1 in tablet dosage formulation. Proguanil hydrochloride was found to be degraded under different set of conditions as followed according to ICH guidelines2 and the degradants so formed along with proguanil hydrochloride were separated using Kromasil C18, 150 mm × 4.6 mm × 5 μm column using Buffer : Methanol (45 : 55) as mobile phase, with a flow rate of 1.2 mL/min with a detection wavelength of 254 nm with injection volume of 20 μL. The method was validated3,4 for specificity, linearity, accuracy, robustness, and precision. The obtained results indicated that the method is selective in analysis of proguanil hydrochloride in the presence of degradation products formed under various stress conditions