STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF REMOGLIFLOZIN ETABONATE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLCAbstract
An accurate, precise, and simple stability-indicating and RP-HPLC method was developed and validated for the estimation of Remogliflozin Etabonate in bulk and pharmaceutical dosage forms. Primacel C18 (150 × 4.6mm, 5µm) column, with mobile phase Acetonitrile: Water (70:30, v/v) at isocratic mode, was used for the development of this method. At wavelength 280nm, and flow rate of 1ml/min was maintained. The retention time for remogliflozin etabonate was about 2.6 min. This method was validated with respect to ICH guidelines for linearity, the limit of detection, the limit of quantification, precision, accuracy, robustness, solution stability, and forced degradation studies. Linearity was performed in the concentration range of 25µg/ml to 150µg/ml with a correlation coefficient of 0.999. The percentage recovery for Remogliflozin Etabonate was found to be within limits of 98% – 102%. The %RSD was also found to be less than 2% which is within limits. Forced degradation studies result in maximum degradation occurred in alkali, acid, and peroxide degradation studies. There was no degradation occurred in photolytic and thermal degradation studies.
K. L. Kanna * and U. P. Panigrahy
Department of Pharmaceutical Analysis, CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.
15 August 2019
10 April 2021
19 May 2021
01 August 2021