Method development and validation for determination of methane sulphonic acid in Rasagiline Mesylate drug substance by ion chromatography with suppressed conductivity detector

A simple method for the detection of Methanesulphonic acid content in Rasagiline Mesylate drug substance using ion chromatography with suppressed conductivity detection is presented. A mixture of 1.3mM Sodium carbonate and 2.0mM Sodium bicarbonate was used as an eluant. The method showed linear responses over the sample target concentration ranges7-13μg/ml. The correlation coefficient was found to be 0.9993. The accuracy of the method was determined by preparing the sample concentration in the ranges 50%, 100% and 120% in triplicate and the % recovery was found to be within 98.0 to 102.0. The Method precision and the intermediate precision were demonstrated by the relative standard deviations (%RSD) of <2% for both the analyst. The Ruggedness was determined by changing the variables such as instrument and different analyst on different days. The method was fully validated for the determination of Methanesulphonic acid content in Rasagiline Mesylate drug substance. And the developed method was validated. The validated method is accurate, reproducibility, repeatability, linear, sensitive, convenience, ease of automation and the cost of analysis.

Author(s): T. Suguna, C. Saravanan, S. Varun Raj, S. Gayathri, M. Tamizh mozhi

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