#TITLE_ALTERNATIVE#

• Main Author: WIGUNA, ARVIN
• Format: Final Project
• Language: Indonesia
• Subjects: Farmakologi dan terapeutik
• Online Access: https://digilib.itb.ac.id/gdl/view/25831
• Institution: Institut Teknologi Bandung

Impurities in pharmaceutical products are compounds that could be degradant from the drugs or <br /> <br /> excipients, or compounds resulted from the reaction between drugs with excipients or others. <br /> <br /> Piroxicam has many impurities that can affect quality, efficacy and safety. This study aims to <br /> <br /> develop a method to analyze contaminants of piroxicam using thin layer chromatography - <br /> <br /> densitometry. The study was began with piroxicam exposure in stress condition, and then <br /> <br /> optimizing eluent composition that can separate piroxicam and its impurity well. Following with <br /> <br /> system suitability test with repeatability and resolution as the parameters is tested. The method <br /> <br /> was validated with linearity, limit of detection, limit of quantification, accuracy, and precision as <br /> <br /> the parameter. From linearity parameter, the regression equation is y = 1097,91 + 856,73x and <br /> <br /> the correlation coefficient is 0,9997. From accuracy parameter the result for recovery test at 16, <br /> <br /> 20, and 24 ?g/spot is 100,49%, 99,97%, and 99,59%. The result coefficient variation from <br /> <br /> precision intraday test is 0,23% and from precision interday test is 0,23%, 1,31%, and 0,75%. <br /> <br /> After the method was validated, the piroxicam content after degradation and ratio between <br /> <br /> piroxicam and its impurity was measured. Then the piroxicam content in capsule and gel from <br /> <br /> commercial products was measured. The result is piroxicam content in capsule is 99,1% and in <br /> <br /> gel is 96,95%. The result showed that analytical method using TLC - densitometry is validated and <br /> <br /> can analyze the impurity of piroxicam in commecial pharmaceutical products. <br />