DEVELOPMENT AND VALIDATION OF A NOVEL STABILITY-INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORMAbstract
A novel stability-indicative of RP-HPLC method was developed and validated for the quantitative estimation of Empagliflozin in bulk drugs and pharmaceutical dosage form in the presence of degradation products. Chromatographic separation was achieved on an Intersil C18 (150mmx4.6mm, 5 μm) analytical column using mobile phase composition of methanol and acetonitrile in ratio of (50: 50 v/v) that was set at a flow rate of 20μl/min with detection of 265 nm. The retention time of Empagliflozin was found to be 2.184min. The high correlation coefficient value indicated clear correlation and their peak area within the LOQ (Limit of quantification) to 150% level. The drug was analyzed by following the guidelines of International conference on Harmonization (ICH) underneath hydrolytic, photolytic, oxidative, and thermal stress conditions. The presentation of the method was validated according to the present ICH guidelines for accuracy, precision and robustness, Linearity, limit of quantification, limit of detection linearity.
N. Padmaja and G. Veerabhadram *
Department of Chemistry, University College of Technology, Osmaina University, Hyderabad, India
30 May, 2016
13 July, 2016
09 August, 2016
01 November, 2016