Simultaneous Spectrophotometric Estimation of Ambroxal Hydrochloride and Guaiphenesin by Area Under Curve Method in Combined Dosage Form

The objective of the study was to develop a simple, accurate, precise and rapid a UV spectrophotometric i.e. area under curve method for the determination of ambroxal and guaiphenesin in combined dosage form i.e. tablets by using distilled water as a solvent. The method was further validated by ICH guidelines. The proposed area under curve method involves the measurement of area at selected analytical wavelength ranges and performing the analysis using “Cramer's rule and Matrix method”.The two analytical wavelengths ranges were used i.e. 239–248 nm and 268–277 nm for estimation of ambroxal hydrochloride and guaiphenesin respectively. The linearity of the proposed method was found in the concentration range of 1–10 μg/ml (r²= 0.9999) for ambroxal hydrochloride and 10–100 μg/ml (r²=0.9999) for guaiphenesin respectively. The percentage mean recovery was found to be 100.124% for ambroxal hydrochloride and 99.98% for guaiphenesin respectively. The method was statistically validated for its linearity, accuracy and precision as per ICH guidelines. Both intra and inter day variation showed less percentage (%) RSD values indicating high grade of precision of this method.