Paper Title
Development and Validation of Analytical Method for Simultaneous Estimation of Gemigliptin and Dapagliflozin in Synthetic Mixture
Article Identifiers
: Authors
Keywords
UV Spectroscopy, RP-HPLC, Method Development and Validation, Validation Parameters
Abstract
A new, precise, rapid and accurate UV Spectrophotometric and RP-HPLC method was developed for the Simultaneous Estimation of Gemigliptin and Dapagliflozin in synthetic mixture. Simultaneous equation UV method was performed on Shimadzu UV-1700 Spectrophotometer based on measurement of Gemigliptin and Dapagliflozin absorption in methanol at 248.40 nm and 224 nm, respectively, over 20-60 μg/ml and 4-12 μg/ml linear ranges. RP-HPLC method was designed using an HPLC system-equipped PDA detector. After optimization of good chromatographic separation was achieved with a mixture of Acetonitrile : Methanol : Ammonium acetate buffer (pH-5.5) in the volume ratio of 60:20:20 %v/v/v as the mobile phase with , C18 column (250 mm × 4.6 mm, 5 µm) as stationary phase at flow rate of 1 ml/min and detection wavelength of 268 nm. The retention time of Gemigliptin and Dapagliflozin was found to be 4.403 min and 8.328 min respectively. The linearity of this method was found in the concentration range of 50 to 250 μg/ml for Gemigliptin and 10 to 50 μg/ml for Dapagliflozin. The correlation coefficient r2 value was found to be 0.9992 for Gemigliptin and 0.9999 for Dapagliflozin. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, specificity and Robustness.
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How To Cite (APA)
Ami Bhoi, Prof. Mitali Dalwadi, & Dr. Umesh Upadhyay (May-2023). Development and Validation of Analytical Method for Simultaneous Estimation of Gemigliptin and Dapagliflozin in Synthetic Mixture. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(5), f171-f186. https://ijnrd.org/papers/IJNRD2305537.pdf
Issue
Volume 8 Issue 5, May-2023
Pages : f171-f186
Other Publication Details
Paper Reg. ID: IJNRD_196146
Published Paper Id: IJNRD2305537
Downloads: 000121984
Research Area: Pharmacy
Author Type: Indian Author
Country: Vadodara, Gujarat, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2305537.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2305537
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