107
Views
2
CrossRef citations to date
0
Altmetric
Original Articles

Development and Validation of Stability Indicating HPTLC-MS Method for Estimation of Empagliflozin in Pharmaceutical Dosage Form

&
Pages 244-256 | Received 20 Jun 2017, Accepted 11 Nov 2017, Published online: 02 May 2018

References

  • Sarashina, A., Ueki, K., Sasaki, T., Tanaka, Y., Koiwai, K., Sakamoto, W., Woerle, H.J., Salsali, A., Broedl, U.C., Macha, S. (2014). Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clinical Therapeutics. 36(11): 1606–1615. doi: 10.1016/j.clinthera.2014.08.001
  • Macha, S., Lang, B., Pinnetti, S., Broedl, U.C. (2014). Pharmacokinetics of empagliflozin, a sodium glucose cotransporter-2 inhibitor, and simvastatin following co-administration in healthy volunteers. International Journal of Clinical Pharmacology and Therapeutics. 52(11): 973–980. doi: 10.5414/CP202117
  • Macha, S., Mattheus, M., Halabi, A., Pinnetti, S., Woerle, H.J., Broedl, U.C. (2014). Pharmacokinetics, pharmacodynamics and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in subjects with renal impairment Diabetes. Obesity and Metabolism. 16(3): 215–222. doi: 10.1111/dom.12182
  • Bhole, R.P., Wankhede & Madhupandey, S.B. (2017). Stability Indicating HPTLC Method for Simultaneous Estimation of Empagliflozin and Linagliptin in Pharmaceutical Formulation. Analytical Chemistry Letters. 7(1): 76–85. doi: 10.1080/22297928.2017.1279567
  • Scheen, A.J. (2014). Pharmacokinetic and pharmacodynamic profile of empagliflozin, a sodium glucose co-transporter 2 inhibitor. Clinical Pharmacokinetics. 53(3): 213–225. doi: 10.1007/s40262-013-0126-x
  • Zhao, X., Cui, Y., Zhao, S., Lang, B., Broedl, U.C., Salsali, A., Pinnetti, S., Macha, S. (2015). Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Single-and multipledose Once-daily Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, in Chinese Patients with Type 2 Diabetes Mellitus. Clinical Therapeutics. 37(7): 1493–1502. doi: 10.1016/j.clinthera.2015.05.001
  • Macha, S., Mattheus, M., Pinnetti, S., Broedl, U.C., Woerle, H.J. (2015). Pharmacokinetics of Empagliflozin and Pioglitazone after Coadministration in Healthy Volunteers. Clinical Therapeutics. 37(7): 1503–1516. doi: 10.1016/j.clinthera.2015.05.002
  • Heise, T., Mattheus, M., Woerle, H.J., Broedl, U.C., Macha, S. (2015). Assessing pharmacokinetic interactions between the sodium glucose cotransporter 2 inhibitor empagliflozin and hydrochlorothiazide or torasemide in patients with type 2 diabetes mellitus: A randomized, openlabel, crossover study. Clinical Therapeutics. 37(4): 793–803. doi: 10.1016/j.clinthera.2014.12.018
  • Bhole, R.P., Jagadale, P.D., Sohan Chitlange, S. and Sagar Wankhede, B. (2015). A Simple and Sensitive HPTLC Method for Simultaneous Analysis of Phenylephrine hydrochlorideand Ketorolac tromethamine in Combined Dose Formulation. Analytical Chemistry Letters. 5(4): 206–215. doi: 10.1080/22297928.2015.1126532
  • Indian Pharmacopoeia. Vol. 2. Government of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission: Ghaziabad. 2007: 427.
  • ICH (Q2A). Harmonized Tripartite Guideline, Text on Validation of Analytical Procedures. Geneva: IFPMA. 1994: 1–5.
  • ICH (Q2B). Harmonized Tripartite Guideline, Validation of Analytical Procedures: Methodology. Geneva: IFPMA. 1996: 1–8.
  • ICH (Q2R1). Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology. Geneva: IFPMA. 2005: 1–13.
  • Nash, R.A., Wachter, A.H. (2003). Pharmaceutical Process Validation. 3rd ed. New York: Marcel Dekker Inc.
  • Singh, S., Bakshi, M. (2002). Guidance on the conduct of stress tests to determine inherent stability of drugs. Pharm. Tech. 24: 1–14.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.