Abstract
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.
Publisher
Indian Drug Manufacturers' Association (IDMA)
Subject
Drug Discovery,Pharmaceutical Science,Pharmacology
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