Archive \ Volume.15 2024 Issue 4

Novel Analytical Method for Combined Dapagliflozin and Vildagliptin in Bulk and Pharmaceutical Dosage Form Using HPLC

Bhavyasri Khagga*✉ , Musquri Nandini , Danda Sowjanya , Dammu Rambabu , Sumakanth Mogili

Abstract

A straightforward, exact, and reliable method has been devised to measure Dapagliflozin and Vildagliptin in bulk or combined tablet dose form concurrently by RP-HPLC. The chromatographic conditions used were an Agilent C18 column (150 x 4.6 mm, 5 mm) with a gradient mode of Orthophosphoric acid: Acetonitrile (pH5) as the mobile phase and a flow rate of 0.7 ml/min. The maximum absorbance was determined to be 224nm by UV Spectrophotometer. Dapagliflozin and Vildagliptin Retention times were found to be 3.5 and 2.1 minutes, respectively. The established method was validated in accordance with ICH Q2 (R1) methods. The Linearity was determined from 0.032:0.32 to 10:100µg/ml. The Percentage RSD was found to be less than 2% which was found to be within the limits. The Accuracy was found to be between 98 to 102% which was found to be within the limits. The robustness data was done by increasing and decreasing the flow rate between 0.6ml and 0.7ml. For the RP-HPLC technique, the concentration range from micrograms/ml yields linear responses.


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Vancouver
Khagga B, Nandini M, Sowjanya D, Rambabu D, Mogili S. Novel Analytical Method for Combined Dapagliflozin and Vildagliptin in Bulk and Pharmaceutical Dosage Form Using HPLC. Arch Pharm Pract. 2024;15(4):5-9. https://doi.org/10.51847/EOs24fQ0wJ
APA
Khagga, B., Nandini, M., Sowjanya, D., Rambabu, D., & Mogili, S. (2024). Novel Analytical Method for Combined Dapagliflozin and Vildagliptin in Bulk and Pharmaceutical Dosage Form Using HPLC. Archives of Pharmacy Practice, 15(4), 5-9. https://doi.org/10.51847/EOs24fQ0wJ

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References
  1. Borse LB, Wagh MS, Borse SL, Ahire SP, Vaishnav IS, Naphade VD, et al. RP-HPLC method development and validation for estimation of dapagliflozin in tablet formulation. J Pharm Negat Results. 2022:364-72.
  2. Gaikwad AV, Gawade AS, Hupparage Vrushabh B, Mantry S, Kale A, Kale J. Method development and validation of dapagliflozin by RP-HPLC. J Pharm Negat Results. 2022;13(06):4316-35.
  3. Dhara V, Hetvi C. Development and validation of UV spectroscopic method for simultaneous estimation of remogliflozin etabonate and vildagliptin in bulk and pharmaceutical dosage form. Asian J Pharm Anal. 2023;13(2):69-73.
  4. Kumari B, Khansili A. Analytical method development and validation of UV-visible Spectrophotometric method for the estimation of vildagliptin in gastric medium. Drug Res (Stuttg). 2020;70(9):417-23. doi:10.1055/a-1217-0296
  5. Chaphekar MM, Hamrapurkar PD. Development and validation of RP-HPLC assay method for vildagliptin using QbD approach and its application to forced degradation studies. Int J Pharm Sci Drug Res. 2016;8(03):157-65. doi:10.25004/ijpsdr.2016.080306
  6. Naveed S, Rehman H, Qamar F, Zainab S. Method development and validation of Vildagliptin using UV spectrophotometer. Int J Pharm Sci Res. 2014;5(10):714-7.
  7. Manasa S, Dhanalakshmi K, Reddy NG, Sreenivasa S. Method development and validation of dapagliflozin in API by RP-HPLC and UV-spectroscopy. Int J Pharm Sci Drug Res. 2014;6(3):250.
  8. Karuna PC, China E, Rao MB. Unique UV spectrophotometric method for reckoning of Dapagliflozin in bulk and pharmaceutical dosage forms. J Chem Pharm Res. 2015;7(9):45-9.
  9. Tripathi KD. Medical pharmacology. 6th edition, Jaypee brothersmedical publishers; 2009.
  10. Rang H, Dale M, Ritter JM, Moore PK. Pharmacology. 5th edition, Elsevier publication; 2006.
  11. Donepudi S, Achanta S. Simultaneous estimation of saxagliptin and dapagliflozin in human plasma by validated high performance liquid chromatography-ultraviolet method. Turk J Pharm Sci. 2019;16(2):227-33. doi:10.4274/tjps.galenos.2018.46547
  12. Tortora GJ, Derrickson B. Principle of anatomy and physiology. 11th edition, John Wiley and son’s publishers; 2006.
  13. Debata J, Kumar S, Jha SK, Khan A. A New RP-HPLC method development and validation of dapagliflozin in bulk and tablet dosage form. Int J Drug Dev Res. 2017;9(2):48-51.
  14. Pallavi K, Srinivasa Babu P, Kishore Babu G. Development and validation of UV spectrophotometric method and RP-HPLC method for estimation of capecitabine in bulk and tablet dosage forms. Int J Appl Pharm. 2016;8(3):24-9.
  15. Chandana M, DR. Rao M, Samrajyam B, Sarissha KSKD, Naga Premi VV. Analytical method development and validation of vildagliptin in pharmaceutical dosage form by RP-HPLC method. J Health Sci Nurs. 2016;1.
  16. Lokhande DP. Analytical method development and validation of teneligliptin by using RP-HPLC with ICH guidelines. Int J Trend Sci Res Dev. 2019;3(3):259-63.

 

 


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