Development of Bioanalytical Method And Validation For Quantification of Brivaracetam In Human Plasma By RP-HPLC

Registration ID: IJNRD_191697

Published ID: IJNRD2304370

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Shubhangi B. Kanoje, Kanchan D. Nagrale, Rita D. Chakole, Manoj S. Charde

Bioanalytical method development, Protein precipitation extraction, Method Validation, Human Plasma, RP-HPLC

High-Performance Liquid Chromatography is an analytical method that has been developed and validated for the estimation of Brivaracetam in Human Plasma according to current regulatory guidelines for bioanalytical methods. Sample processing involved a simple protein precipitation extraction technique by acetonitrile as the extraction solvent. Methods: Separation is carried out on Sunfire-C18 plasma 5 µm (4.6 × 250 mm) column as a stationary phase, Mobile Phase: methanol + 0.1% OPA (orthophosphoric acid) in ratio (45: 55), at a flow rate of 0.7 ml/min. The sample was detected at a wavelength of 279 nm and the sample size was 20μl. The objective of method validation, according to ICH principles, is to show that an analytical technique is appropriate for the intended use. The standard calibration plot was found linear over a range of 10 to 50 µg/ml and the correlation coefficient was found to be (R2 =0.999). The % RSD value of intraday and interday precision is 0.17 and 0.04 respectively. The LOD and LOQ were found to be 0.115034 and 0.34587 for Brivaracetam. The developed method was eventually applied for quantification of the marketed formulation satisfactory result was obtained. Conclusions: It can be concluded that the developed bioanalytical method is capable of quantifying Brivaracetam from spiked human plasma samples. The method meets the requirements of the USFDA Guidelines and can be applied to Bioavailability/ Bioequivalence studies of Brivaracetam.

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Shubhangi B. Kanoje, Kanchan D. Nagrale, Rita D. Chakole, & Manoj S. Charde (April-2023). Development of Bioanalytical Method And Validation For Quantification of Brivaracetam In Human Plasma By RP-HPLC. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(4), d490-d499. https://ijnrd.org/papers/IJNRD2304370.pdf

Volume 8 Issue 4, April-2023

Pages : d490-d499

Paper Reg. ID: IJNRD_191697

Published Paper Id: IJNRD2304370

Downloads: 000121992

Research Area: Pharmacy

Author Type: Indian Author

Country: Karad, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2304370.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2304370

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

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