Development and validation of stability indicating UV-visible spectrophotometric method for simultaneous determination of salbutamol sulphate and ambroxol hydrochloridein liquid dosage form

Abstract

Purpose: A new, simple, precise and validated UV spectrophotometric method has been developed for simultaneous estimation of salbutamol sulphate and ambroxol hydrochloride in liquid dosage form. Method: The method employed was simultaneous equation method which involves solving simultaneous equations based on measurement of absorbance at two wavelengths 224 nm and 244 nm, the λmax of salbutamol sulphate and ambroxol hydrochloride, respectively. Specificity of the method was determined by subjecting the drugs to various stress conditions like acid, alkali, thermal and photolytic degradation. Results: The linearity was obtained in the concentration range of 0.1-0.6 μg/mL for salbutamol sulphateand 1.5-09 μg/mL for ambroxol hydrochloride. The proposed method was effectively applied to liquid dosage form for estimation of both drugs. The accuracy and reproducibility results are close to 100% with ≤2% RSD. The results of proposed method have been validated as per ICH guidelines. Conclusion: A novel, precise and accurate stability indicating spectrophotometric method has been developed for the estimation of salbutamol sulphate and ambroxol hydrochloride in pharmaceutical syrup formulation.