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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: | Bioanalytical Method Development and Validation of Antidiabetic Drug: Imeglimin Hydrochloride |
| Authors Name: | Ms. Kartika Anantrao Gawande |
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| Author Reg. ID: |
IJRTI_204147
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| Published Paper Id: | IJRTI2505246 |
| Published In: | Volume 10 Issue 5, May-2025 |
| DOI: | |
| Abstract: | A simple, rapid, sensitive, and cost-effective isocratic reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the bioanalytical estimation of Imeglimin Hydrochloride in human plasma. Imeglimin, a novel oral antidiabetic agent, belongs to the "glimins" class and exhibits a unique dual mechanism of action by enhancing insulin secretion and sensitivity. At a flow rate of 1.0 mL/min, the technique used a C18 column (Hypersil BDS, 250 × 4.6 mm, 5 µm) with a mobile phase made of methanol and ammonium formate buffer (80:20 v/v) with UV detection at 238 nm. The retention time of Imeglimin Hydrochloride was observed to be approximately 3.57 minutes, indicating a relatively short analysis time. The method was validated as per USFDA guidelines, demonstrating excellent specificity with no interference from blank plasma. Across a concentration range of 12–38 µg/mL, linearity was verified with a correlation coefficient (R2) of 0.9998. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.51 µg/mL and 1.53 µg/mL, respectively. Accuracy studies showed mean recoveries between 98.09% and 99.37%, while precision (intra- and inter-day) results displayed %RSD well within 2%, indicating reproducibility. The method was further proven robust and rugged through deliberate variations in analytical conditions such as flow rate, wavelength, operators, and reagent sources, with acceptable %RSD values confirming method reliability. Protein precipitation using methanol was employed for plasma sample preparation, ensuring efficient extraction. Due to its simplicity, low retention time, economic mobile phase, and high resolution, the developed RP-HPLC method is highly suitable for routine analysis and pharmacokinetic studies of Imeglimin Hydrochloride in biological matrices. |
| Keywords: | Imeglimin Hydrochloride, RP-HPLC, Bioanalytical, Development, Validation, Type 2 diabetes (T2D), % RSD. |
| Cite Article: | "Bioanalytical Method Development and Validation of Antidiabetic Drug: Imeglimin Hydrochloride ", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 5, page no.c392-c398, May-2025, Available :http://www.ijrti.org/papers/IJRTI2505246.pdf |
| Downloads: | 000579 |
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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: IJRTI2505246
Registration ID:204147
Published In: Volume 10 Issue 5, May-2025
DOI (Digital Object Identifier):
Page No: c392-c398 Country: Tq- Daryapur Dist- Amravati, Maharashtra , India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2505246 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2505246 |
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ISSN: 2456-3315
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