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International Journal for Research Trends and Innovation
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ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Impact Factor : 8.14
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| Paper Title: | DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, GLIMEPIRIDE AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM |
| Authors Name: | Dhvani D. Joshi , Dr. Jimish R. Patel , Dr. Maulik R. Mehta |
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IJRTI_202854
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| Published Paper Id: | IJRTI2504219 |
| Published In: | Volume 10 Issue 4, April-2025 |
| DOI: | |
| Abstract: | The given RP-HPLC technique was found to be clear-cut, specific, exact, and economical for estimation of Dapagliflozin Propanediol Monohydrate, Glimepiride and Metformin Hydrochloride in Tablet Dosage Form. The method was validated according to the international conference on harmonization guidelines. A reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed utilizing an Agilent Zorbax SB-CB column (250 x 4.6 mm, 5 µm) as the stationary phase. The mobile phase consisted of a buffer, acetonitrile (ACN), and methanol in a 35:5:60 %v/v/v ratio. The sample injection was performed at a flow rate of 1.0 mL/min, with detection carried out at a wavelength of 228 nm. The developed method demonstrated linearity in the concentration ranges of 5–15 µg/mL for Dapagliflozin Propanediol Monohydrate, 1–3 µg/mL for Glimepiride, and 500–1500 µg/mL for Metformin Hydrochloride. The correlation coefficients (r²) were found to be 0.9993, 0.9991, and 0.9989, respectively, indicating excellent linearity. Precision studies showed that the percentage relative standard deviation (% RSD) was below 2%, confirming method repeatability. Robustness evaluation also yielded % RSD values below 2%, demonstrating method reliability under small variations in conditions. Accuracy was assessed through a recovery study, ensuring the method's suitability for quantitative analysis. |
| Keywords: | Dapagliflozin Propanediol Monohydrate, Glimepiride, Metformin Hydrochloride, RP-HPLC, Method Development and Validation. |
| Cite Article: | "DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, GLIMEPIRIDE AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 4, page no.b952-b966, April-2025, Available :http://www.ijrti.org/papers/IJRTI2504219.pdf |
| Downloads: | 000590 |
| ISSN: |
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID: IJRTI2504219
Registration ID:202854
Published In: Volume 10 Issue 4, April-2025
DOI (Digital Object Identifier):
Page No: b952-b966 Country: Himmatnagar, Gujarat, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2504219 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2504219 |
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ISSN: 2456-3315
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