Affiliation:
1. B. K. MODY GOVERNMENT PHARMACY COLLEGE, RAJKOT
2. B. K. Mody Government Pharmacy College
Abstract
For the quantitative measurement of Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate in synthetic mixture form in the presence of its degradants, precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises [Methanol: 20 mM Ammonium formate (70:30 v/v)] at a flow rate of 1.0 ml/min, injection volume of 20 µl, and UV detection at 225 nm. Separation was accomplished using Gemini, C18 column. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate were eluted with retention times of 6.65 minutes and 4.20 minutes, respectively. This procedure was approved following ICH guideline Q2 (R1). The calibration plots for Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate have correlation coefficients of 0.9995 and 0.9996 over the concentration ranges of 5-100 µg/ml and 10-200 µg/ml respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, accuracy ranged from 99.81-100.78% and 99.13-100.69%, respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, the LOD was found to be 0.947 µg/ml and 1.355 µg/ml. In contrast, the LOQ was 2.869 µg/ml and 4.107 µg/ml, respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants.
Publisher
The Turkish Chemical Society
Reference48 articles.
1. 1. "Drug Profile and Information of Dapagliflozin Propanediol Monohydrate", October 2023, Available from:
2. 2. "Drug Profile and Information of Dapagliflozin Propanediol Monohydrate", October 2023, Available from:
3. 3. Vyas AJ, Gol DA, Patel AI, Patel AB, Patel NK, Chavda JR, Lumbhani A, Chudasama A. Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method. Analytical Chemistry Letters. 2021;11(4):539-552. Available from:
4. 4. Vyas AJ, Patel SM, Patel AB, Patel AI, Patel NK. Stability testing: An Essential study for Vaccine Formulation Development. Asian Journal of Pharmaceutical Analysis. 2022;12(1):29-6. Available from:
5. 5. Vyas AJ, Visana NM, Patel AI, Patel AB, Patel NK. Analytical Quality by Design in Stress Testing or Stability-Indicating Method. Asian Journal of Pharmaceutical Analysis. 2021;11(2):170-178. Available from: