Alternative liquid chromatographic method to gas chromatography for the determination of acetic acid in pharmaceuticals

Abstract

A simple, accurate and precise validated method has been developed for determination of acetic acid fro pharmaceuticals. 0.1% Ortho phosphoric acid is used as a Mobile phase A with Acetonitrile (Mobile phase B). Separation of Acetic acid achieved using L1 column of 150x4.6mm, 5µ dimension. Flow rate was 1.0mL/minute and 210 nm was the detector wavelength. Method has been extensively validated as per ICH guideline for parameters like Specificity, Linearity, Precision, Accuracy, solution stability, filter compatibility and robustness. Accuracy for Acetic acid is 100.8%. Correlation coefficient for Acetic acid is found 0.99, all other validation parameters found ok. Literature survey revealed that, there is no method reported for the determination of Acetic acid in pharmaceuticals by using liquid chromatography. The proposed method is very simple, accurate, precise and alternative option to Gas chromatography. Hence, this validated novel liquid chromatographic method can be easily and conveniently adopted for routine analysis of Acetic acid content from pharmaceuticals.