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

  1. Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad-500027, India

     

  2. Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad-500027, India. 

     

  3. Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad-500027, India.

  4. Gland Pharma Pvt. Ltd, Hyderabad, India. 

     
  5. Department of Pharmaceutical Chemistry, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad-500027, India.

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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