RP-HPLC Procedure Development and Validation for Teneligliptin and Pioglitazone Concurrent Quantification in Bulk and Pharmaceuticals with greenness and practicality assessment

The present effort’s objective is developing an environmentally friendly, operator-safe RP-HPLC procedure for the concurrent quantification of Teneligliptin (TEN) and Pioglitazone (PIO) in bulk as well as tablets and validating as per criteria of ICH. Kromasil C₁₈ column, mobile phase consisting 60 volumes of Ammonium acetate buffer (pH 3) along with 40 volumes of Acetonitrile forced at 1ml/min flow rate for the chromatographic separation using PDA. Separation of TEN and PIO was achieved at respective retention times of 2.470 min and 3.174 min. ICH recommendations Q2(R1) were utilized to validate the present procedure. The procedure was perceived to be linear in the concentration ranges of 5-30 µg/ml and 3.75-22.5 µg/ml respectively, for TEN and PIO. The detection and quantification limits for TEN and PIO were 0.07(µg/ml), 0.05(µg/ml) and 0.22(µg/ml), 0.15(µg/ml) respectively. ICH recommendations Q1A(R2) and Q1B were observed for executing forced degradation studies. Various metrics like AGREE, MoGAPI and BAGI were utilized for greenness and applicability assessment of the proposed technique. The procedure can be utilized for routine laboratory determination and quality control focused on the concurrent quantification of TEN and PIO.