Quality by Design (QbD) Approach to Develop and Validate a HPLC Method for Piroxicam from Serum

Autor: Iuliean Vasile Asaftei, Adrian Spac, Alina Monica Miftode, Ion Sandu
Rok vydání: 2018
Předmět:
Zdroj: Revista de Chimie. 69:2167-2171
ISSN: 2668-8212
0034-7752
DOI: 10.37358/rc.18.8.6492
Popis: Piroxicam belongs to the non-steroidal antiinflammatory class, it is utilized as analgesic, anti-inflammatory and antipyretic. A simple and accurate HPLC method was optimized and validated in the QbD approach, for the determination of piroxicam in serum. The optimization of HPLC analysis was performed using different columns, mobile phases and flows. The HPLC method was appropriately validated for linearity, limit of detection, limit of quantification, precision and accuracy in accordance with the ICH guidelines. The optimized and validated method proved to be simple, precise, and accurate, and can be successfully applied for the determination of piroxicam in serum.
Databáze: OpenAIRE