¹Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India - 533003
²Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati, Andhra Pradesh, India – 517502 DOI : 10.29228/jrp.848 The objective of the present effort is developing a fully green-assessed stability-indicating reverse phase liquid chromatography for the assessable measurement regarding Remogliflozin etabonate (RGE) & Teneligliptin (TEN) in drug substance and tablets and fully validated as per ICH criteria. Waters Atlantis T3 (150mm x 4.6, 3.5μm) column, 30 volumes acetonitrile along with 70 volumes ammonium formate (pH-3.0) mobile phase pumped at a flow rate of 1.0ml/min were used for the chromatographic separation using PDA exposure at 236 nm wavelength. Remogliflozin etabonate, Teneligliptin were separated at 2.730, 4.468 minutes of retention times respectively. ICH guidelines Q2 R1 was employed to validate the current procedure. Accuracy measurements were acceptable to intra-day and inter-day measurements. For RGE & TGN, respectively, the recommended technique was linear in the concentration ranges of 25– 150μg/ml and 2.5–15 μg/ml. y=29777x+67797 and y= 30689 x +22270 respectively were the observed regression equations for RGE and TEN. The limits of detection (LOD) and quantification (LOQ) for Remogliflozin etabonate & Teneligliptin were respectively 0.3 (μg/ml), 1 (μg/ml) and 0.03(μg/ml), 0.1(μg/ml). The recovery percentage of the method was found to remain in between 98% and 100%. Q1A R2 and Q1B guidelines were followed for conducting stability-indicating studies. The technique can also be utilized for quality control and repetitive laboratories evaluation aimed at the simultaneous assessment of RGE & TEN in the drug substance and pharmaceutical dosage form. Keywords : RP-HPLC; Remogliflozin etabonate; Teneligliptin; Validation; Forced degradation studies; ICH guidelines