METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF NEW RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN AND TENELIGLIPTIN IN PURE AND TABLET DOSAGE FORM

According to ICH guidelines, an easy, cost-effective, accurate, and precise RP-HPLC method for simultaneously determining Remogliflzin and Teneligliptin was developed and validated. The drug’s quantity was determined using a photodiode array (PDA) detector. The column was run in isocratic mode with mobile phase acetonitrile and ammonium phosphate buffer at a 40:60 ratio. The flow rate was one milliliter per minute and effluent was measured at 245 nm. The retention times were 2.719 and 7.337 min for Remogliflzin and Teneligliptin respectively. The injection volume was 10µl. as per ICH guidelines the method was validated and the method was found to be linear in the range of 25-150µg/ml for Remogliflzin and 2.5-15µg/m for Teneligliptin. Percentage recovery studies of Remogliflzin and Teneligliptin100.2% and 100%. The LOD & LOQ was found to be 0.3 & 1µg/ml for Remogliflzin and 0.03 & 0.1µg/ml for Teneligliptin. The values of precision and robustness lie within the acceptance limit. Thus, the simultaneous determination of Remogliflzin and Teneligliptin using the suggested method can be successfully employed in routine analysis. Remogliflzin and Teneligliptin were studied for forced degradation in controlled, acidic, basic, peroxide, reduction, UV, thermal and hydrolysis conditions.