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A novel, specific, sensitive, accurate and economical stability indicating RP-HPLC method was developed for the estimation of Phenylephrine hydrochloride and Bromhexine hydrochloride in their tablet dosage form. Separation was achieved on C18 column (250 × 4.6 mm, 5μm) using Optimized Mobile Phase Water: Acetonitrile (60:40 % v/v) (pH adjusted to 4.5 with 1% OPA) and flow rate maintained at 1.0 ml/min was used. Wavelength was monitored at 215 nm. Both the drugs were subjected to acid, base, oxidation, thermal and photolytic degradation conditions. The retention time of PHN and BHX were found to be 3.24 min and 7.11 min respectively. The linearity response was observed in range of 5-25 μg/ml and 4-20 μg/ml of PHN and BHX respectively. Force degradation study revealed that maximum degradation of PHN and BHX was occur in Photolytic degradation. (Standard 19.88%, Sample 18.07% and standard 19.81%, Sample 18.26%) respectively. % RSD was found to be less than 2 in precision, Robustness, LOD and LOQ. % recovery was found in range 98-102%.The proposed method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

journal of current pharma research

A novel stability indicating RP-HPLC method development and validation for estimation of Phenylephrine hydrochloride and Bromhexine hydrochloride in their tablet dosage form.