Development and Validation of Stability Indicating HPLC Method for Simultaneous Estimation of Acetamenophene, Chlorphenarimine Maleate and Phenylephrine in Tablet Dosage Formulation

Abstract

A new Stability indicating high performance liquid chromatographic (HPLC) method was developed for the determination of Acetamenophene, phenylephrine hydrochloride, and Chlorpheniramine maleate in combined pharmaceutical Tablet dosage forms. Different Pure Solvents With Different Proportions are Tried as Mobile Phase For the Development of method. The separation of all Individual peaks was achieved on Synergy 4 μ Hydro-RP 80A (250 mm×4.6μ m), C18 column, using gradient elution of Buffer(1ml T.F.A in 1000 ml Water) : (Mobile phase A) and Acetonitrile (Mobile phase B) at flow rate of 0.8 mL/min and Quantification was achieved by PDA detector at wavelength 275nm with the total run time of 22 min. Retention time of phenylephrine hydrochloride was found at 3.2min Acetamenophene at 4.7 min And Chlorpheniramine Maleate found at 10.6 min. As results optimum retention time and good resolution obtained with Appropriate tailing factor. The method was validated with respect to linearity, precision, accuracy and recovery. Further, Degradation Studies of the method was performed . Forced degradation of Analytes was carried out under acidic, basic, oxidative, thermal And humidity conditions.This simple, fast, economical and precise high performance liquid chromatographic method can be adopted for routine quality control analysis. The method was found to be specific enough to separate degradation products from main Analytes.