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.
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