Shantaram Gajanan Khanage* , Department of Pharmaceutical chemistry, N. M. S. M.’ S Abasaheb Kakade College of B. Pharmacy, Bodhegaon, Tq-Shevgaon, Dist.-Ahmednagar, Maharashtra, India-414503.
Sangita Bhausaheb Shende, Department of Quality assurance technique and PG studies, M. E. S.’S College of Pharmacy, Sonai, Tq-Newasa, Dist.-Ahmednagar, Maharashtra, India-414105.
A simple, specific, precise and accurate RP-HPLC method has been developed for simultaneous estimation of Metformin (MET) and Teneligliptin (TEN) in tablet formulation. In the RP-HPLC method separation was achieved by HiQ silC-18 HS column (250 mm× 4.6 mm), with mobile phase containing Methanol: Buffer (Ammonium acetate) (70:30 v/v) and the Buffer was adjusted to pH 4 by Glacial acetic acid for. The flow rate was 1.2 mL/min and effluent was monitored at 249 nm. The retention time of MET and TEN were 2.29 min and 4.30 min respectively. The linearity for MET and TEN were in the range of 5-25 µg/mL and 5-25 µg/mL respectively. The recoveries of MET and TEN were found within the limits. The proposed method was validated as per ICH guidelines by means of different parameters likes Linearity, Precision, Accuracy, Limit of detection, Limit of quantitation, Range, Selectivity, Robustness Ruggedness, Solution stability and successfully applied to the estimation of MET and TEN in tablet dosage form.
Keywords: Metformin, Teneligliptin, RP-HPLC, Analytical method, Validation.
Download pdf: Shantaram Gajanan Khanage et al, The Experiment, 2018, Vol 45(2),