CHEMOMETRICS ASSISTED STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ACETYL CYSTEINE AND AMBROXOL HYDROCHLORIDE IN BULK AND DOSAGE FORM

A simple and precise stability indicating RP-HPLC method was developed for the simultaneous estimation of acetyl cysteine and ambroxol hydrochloride in bulk and dosage form. Experimental design based evaluation using a 23 full factorial design was applied to evaluate coefficient, ANOVA for the establishment of robustness nature of the method. Kromosil (250 mm x 4.6 mm, 5 μ) C18 column at 274 nm of UV detection was used. A composition of 0.1 % ortho phosphoric acid and acetonitrile in the ratio of 28:72 (V:V) was used as the mobile phase with a flow rate of 1.0 mL min-1. Linearity was established over the concentration range of 50-300 μg. mL-1 for acetyl cysteine and 7.5-45 μg mL-1 for ambroxol hydrochloride. The proposed method was validated and was successfully utilized for the quantitative analysis of tablet formulations containing acetyl cysteine and ambroxol hydrochloride.