Abstract
A novel combination of Acebrophylline and Acetylcysteine is used in the treatment of chronic obstructive pulmonary disease (COPD) and bronchial asthma. A simple, economic, sensitive, accurate and reproducible spectroscopic method has been developed and validated for the simultaneous estimation of Acebrophylline and Acetylcysteine in capsule dosage form by Simultaneous equation method. Acebrophylline and acetylcysteine were found to have absorbance maxima at 273 and 220 nm respectively in distilled water. Acebrophylline was found to be linear in the concentration range of 1 to 6 mu g/ml at 273 nm and Acetylcysteine was found to be linear in the concentration range of 6 to 36 mu g/ml at 220 nm. The LOD and LOQ were found to be 6.22 mu g/ml and 18.84 mu g/ml (at 273nm) for Acebrophylline and 36.64 mu g/ml and 111.04 mu g/ml at (220nm) for Acetylcysteine respectively. The recovery of Acebrophylline and Acetylcysteine were found to be 101.86% and 99.54% respectively showing accuracy of the method. The assay of marketed tablet formulation (Pulmoclear Capsules) was found to be 101.81% and 99.82% 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. So, the proposed method was found to be simple, specific, precise, accurate and linear. Hence it can be applied for routine analysis of Acebrophylline and Acetylcysteine in pharmaceutical formulations.