Development and Validation of RP-HPLC method for simultaneous estimation of Glimepiride and Linagliptin from their Synthetic Mixture

Registration ID: IJNRD_219617

Published ID: IJNRD2404700

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Ms. Falguni Dasila Pratapsinh , Ms. Seju Patel , Ms. Janki Patel , Dr. Vanita Marvaniya , Dr. L.M Prajapati

Glimepiride, Linagliptin, RP-HPLC, validation parameter, Method development and validation

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.

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Ms. Falguni Dasila Pratapsinh, Ms. Seju Patel, Ms. Janki Patel, Dr. Vanita Marvaniya, & Dr. L.M Prajapati (April-2024). 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, 9(4), g787-g802. https://ijnrd.org/papers/IJNRD2404700.pdf

Volume 9 Issue 4, April-2024

Pages : g787-g802

Paper Reg. ID: IJNRD_219617

Published Paper Id: IJNRD2404700

Downloads: 000121979

Research Area: Pharmacy

Country: Ahmedabad , Gujarat, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2404700.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2404700

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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