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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) |
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| Paper Title: | Development of Bioanalytical Method And Validation For Quantification of Brivaracetam In Human Plasma By RP-HPLC |
| Authors Name: | Shubhangi B. Kanoje , Kanchan D. Nagrale , Rita D. Chakole , Manoj S. Charde |
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IJNRD_191697
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| Published Paper Id: | IJNRD2304370 |
| Published In: | Volume 8 Issue 4, April-2023 |
| DOI: | |
| Abstract: | 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. |
| Keywords: | Bioanalytical method development, Protein precipitation extraction, Method Validation, Human Plasma, RP-HPLC |
| Cite Article: | "Development of Bioanalytical Method And Validation For Quantification of Brivaracetam In Human Plasma By RP-HPLC", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 4, page no.d490-d499, April-2023, Available :http://www.ijnrd.org/papers/IJNRD2304370.pdf |
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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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Published Paper ID:IJNRD2304370 Registration ID: 191697 Published In: Volume 8 Issue 4, April-2023 DOI (Digital Object Identifier): Page No: d490-d499 Country: Karad, Maharashtra, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2304370 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2304370 |
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
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