Abstract

Q-ABSORBANCE RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF ACETYLCYSTEINE AND ACEBROPHYLLINE

Tvinkal P. Patel*, Laxman M. Prajapati, Amit K. Joshi, Mohammadali L. Kharodiya

ABSTRACT

A simple, economic, sensitive, accurate and reproducible spectroscopic method has been developed and validated for the simultaneous estimation of acebrophylline and acetylcysteine in tablet dosage form by Q-Absorbance ratio method. Acebrophylline and acetylcysteine were found to have absorbance maxima at 274 and 195 nm respectively in distilled water and iso absorptive point was found to be 210 nm. Acebrophylline was found to be linear in the concentration range of 5 to 11 μg/ ml at 274 nm and Acetylcysteine was found to be linear in the concentration range of 30 to 66 μg/ml at 195 nm. The assay of marketed tablet formulation (Pulmoclear Tablet) was found to be 103.4% and 101.58% for acebrophylline and acetylcysteine respectively. The method was validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2.

Keywords: Acetylcysteine, Acebrophylline, Q-Absorbance ratio method, Validation, ICH.