Abstract

Development and validation of gas chromatography method for the determination of residual solvents in Mirabegron

Author(s): Chusena Narasimharaju Bhimanadhuni and Devala Rao Garikapati

A simple and reliable head space Gas chromatographic method was developed for the determination of methanol, Diethyl Ether, Isopropyl alcohol and Toluene as residual solvents present in Mirabegron. The proposed method is based on flame ionization detection technique with DB-624 (60m × 0.53 × 3μm) as stationary phase. The carrier gas flow was at 41.4 kPa using pressure mode and the sample was introduced with slit ratio 1:10 The capillary injector temperature set at 220°c and FID-detector set at 240°c. The column temperature was 50°c for 5min, further the temperature ramp set at 15°c /min to attain 230°c, and then hold for 3min, the chromatograph stop time was set to 20min. The concentration ranges between 15-90μg/ml for methanol, 25-150μg/ml for Diethyl Ether, 25-150μg/ml for isopropyl alcohol and 4.45-26.7μg/ml for toluene respectively. The propose method was validated as per the ICH guidelines. The method was accurate, precise, and rapid found to be suitable for the quantitative analysis of the residual solvents present in Mirabegron.

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