Validated high performance liquid chromatographic method for determination of Rasagiline Mesylate under oxidative, photolytic and thermal stress Conditions

نویسندگان

  • P. G. Shelke
  • A. V. Chandewar
  • P. Wadhwani
چکیده

The high performance liquid chromatographic method was developed for the determination of Rasagiline Mesylate in presence of its degradation products. As per the ICH guidelines Q1A (R2), forced degradation study was carried out under oxidative, photolytic and thermal stress conditions. The analysis of stressed samples was carried out using Prontosil C18 column. The mobile phase comprised of methanol and phosphate buffer (pH 3.0) in the ratio 75:25 (v/v) for 1 min and then changed to 90:10 (v/v) in next 9 min by HPLC gradient programming. The flow rate was maintained at 1.0 ml/min and detection wavelength was 210 nm using PDA detector. The validation of developed method was carried out in terms of linearity, precision, accuracy, specificity and selectivity.

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تاریخ انتشار 2014