INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
The RP-HPLC was used to develop the method and for validation of glimepiride and linagliptin from synthetic mixture. For chromatographic condition the mobile phase used was Acetonitrile: Methanol: Water (35:35:30 v/v) on the stationary phase of Hibar ODS C18 column (250 mm*4.6 mm), the detection observed was at 245nm. The response of the calibration curve was found to be linear in range by Glimepiride and Linagliptin 0.9996 and 0.9998 respectively. The retention time observed is 3.198 min for Glimepiride and 7.401 min for Linagliptin at the run time of 15 minutes. The limit of detection for Glimepiride is 0.035 μg/mL and Linagliptin is 0.08 μg/mL. However, the limit of quatification for Glimepiride is 0.10 μg/mL and Linagliptin is 0.08 μg/mL. The accuracy for the Glimepiride is 99.98% and Linagliptin is 99.78 % as per method performed. The limit for precision is RSD< 2 therefore, for Glimepiride is 0.59-1.14 and Linagliptin is 0.46-1.21. The experiment was carried out as per International Conference on Harmonization (ICH) guidelines and the statistical analysis of the data is linear, precise, accurate and robust. Therefore, the method can be successfully employed for the synthetic mixture of glimepiride and linagliptin in pharmaceutical formulation.
Keywords:
Glimepiride, Linagliptin, RP-HPLC, validation parameter, Method development and validation
Cite Article:
"Development and Validation of RP-HPLC method for simultaneous estimation of Glimepiride and Linagliptin from their Synthetic Mixture", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.9, Issue 4, page no.g787-g802, April-2024, Available :http://www.ijnrd.org/papers/IJNRD2404700.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 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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