METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN API BY RP-HPLC AND UV-SPECTROSCOPY
Abstract
In the present study, two analytical methods were developed for the estimation of Dapagliflozin in API. Method A: RP-HPLC method, Method B: UV spectroscopic method. In method A, the drug showed linearity in the range of 25-150µg/ml with a correlation coefficient (r2) of 0.999, where as in method B, the linearity range was found to be 1-5µg/ml with a correlation coefficient of (r2) 0.999. Both the methods were validated for different validation parameters such as linearity, accuracy, precision, detection limit, quantitation limit, robustness and ruggedness and the results were found to be within the acceptance limits as per the guidelines of International Conference on Harmonization (ICH).
Keywords:
Dapagliflozin, UV-spectroscopy, RP-HPLC, International Conference on HarmonizationDOI
https://doi.org/10.25004/IJPSDR.2014.060317References
1. Edward Chao C, Robert Henry R. SGLT2 inhibition-a novel strategy for diabetes treatment. Nature Reviews Drug Discovery 2010; 10: 1-9.
2. Aubry AF, Gu H, Magnier R, Morgan L, Xu X, Tirmenstein M, Wang B, Deng Y, Cai J, Couerbe P, Arnold M. Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis 2010; 2 (12):2001-2009.
3. Obermevier M, Yao M, Khannna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W, Ellsworth B.A, Whaley J.M, Humphreys W.G. In-vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium glucose co-transporter type II inhibitor, in animals and humans. Drug Metabolism and Disposition 2010; 38(3):405-414.
4. Mudaliar S, Henry RR, Boden G. Changes in insulin sensitivity and insulin secretion with the sodium glucose co transporter 2 inhibitor dapagliflozin. Diabetes Technology and Therapeutics 2014; 16(3): 137-144.
5. Merovci A, Solis-Herrera C, Daniele G, Eldor R, Fiorentino TV, Tripathy D, Xiong J, Perez Z, Norton L, Abdul-Ghani MA, DeFronzo RA. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. The Journal of Clinical Investigation 2014; 124(2): 509-514.
6. Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, a sodium glucose cotransporter-2 inhibitor, on hemoglobin A1C, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone Monotherapy. Diabetes Care 2012; March:1-6.
7. Bailey CJ, Gross JL, Peters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomized, double-blind, placebo-controlled trial. Lancet. 2010; 375:2223-2233.
8. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: A randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010; 33:2217-2224.
9. Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes, Obesity and Metabolism. 2013; 15:853-862.
10. Wilding JPH, Norwood P, T’joen. C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers. Diabetes Care. 2009; 32(9):1656-1662.
11. Jadoon K, Idris I. Dapagliflozin: A once-daily oral therapy sodium-glucose cotransporter-2 inhibitor for the treatment of adult patients with type 2 diabetes. Clinical Medical Insights: Therapeutics. 2011; 3:185-194.
2. Aubry AF, Gu H, Magnier R, Morgan L, Xu X, Tirmenstein M, Wang B, Deng Y, Cai J, Couerbe P, Arnold M. Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis 2010; 2 (12):2001-2009.
3. Obermevier M, Yao M, Khannna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W, Ellsworth B.A, Whaley J.M, Humphreys W.G. In-vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium glucose co-transporter type II inhibitor, in animals and humans. Drug Metabolism and Disposition 2010; 38(3):405-414.
4. Mudaliar S, Henry RR, Boden G. Changes in insulin sensitivity and insulin secretion with the sodium glucose co transporter 2 inhibitor dapagliflozin. Diabetes Technology and Therapeutics 2014; 16(3): 137-144.
5. Merovci A, Solis-Herrera C, Daniele G, Eldor R, Fiorentino TV, Tripathy D, Xiong J, Perez Z, Norton L, Abdul-Ghani MA, DeFronzo RA. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. The Journal of Clinical Investigation 2014; 124(2): 509-514.
6. Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, a sodium glucose cotransporter-2 inhibitor, on hemoglobin A1C, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone Monotherapy. Diabetes Care 2012; March:1-6.
7. Bailey CJ, Gross JL, Peters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomized, double-blind, placebo-controlled trial. Lancet. 2010; 375:2223-2233.
8. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: A randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010; 33:2217-2224.
9. Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes, Obesity and Metabolism. 2013; 15:853-862.
10. Wilding JPH, Norwood P, T’joen. C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers. Diabetes Care. 2009; 32(9):1656-1662.
11. Jadoon K, Idris I. Dapagliflozin: A once-daily oral therapy sodium-glucose cotransporter-2 inhibitor for the treatment of adult patients with type 2 diabetes. Clinical Medical Insights: Therapeutics. 2011; 3:185-194.
Published
01-07-2014
Statistics
Abstract Display: 2697 
PDF Downloads: 1461
Dimension Badge
How to Cite
“METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN API BY RP-HPLC AND UV-SPECTROSCOPY”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 3, July 2014, pp. 250-2, https://doi.org/10.25004/IJPSDR.2014.060317.
Issue
Section
Research Article
How to Cite
“METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN API BY RP-HPLC AND UV-SPECTROSCOPY”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 3, July 2014, pp. 250-2, https://doi.org/10.25004/IJPSDR.2014.060317.
