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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, ef...
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| Format: | Final Project |
| Language: | Indonesia |
| Subjects: | |
| Online Access: | https://digilib.itb.ac.id/gdl/view/25831 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | 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 />
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