USFDA-Guideline Based Validation of Testing Method for Ciprofloxacin in Indonesian Serum Specimen
Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugsshould shown bioequivalence with the originator drug prior to registration. Bioequivalence testing (BE-testing) has to be performed to the people that represented of population to which the drug to be administrated...
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| Main Authors: | , , |
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| Format: | Conference or Workshop Item NonPeerReviewed |
| Language: | English |
| Published: |
2009
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| Subjects: | |
| Online Access: | https://repository.ugm.ac.id/275152/1/ICS%20Tri%20joko.pdf https://repository.ugm.ac.id/275152/ |
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| Institution: | Universitas Gadjah Mada |
| Language: | English |
| Summary: | Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugsshould shown bioequivalence with the originator drug prior to registration. Bioequivalence testing (BE-testing) has to be performed to the people that represented of population to which the drug to be administrated. BE testing need a valid bioanalytical method for certain drug target and group of
population. This research report specific validation of bioanalysis of ciprofloxacin in Indonesian serum specimen in order to be used for BE testing. The extraction was performed using acetonitrile while the chromatographic separation was accomplished on a Chromolith RP 18 column (100 x 4.6 mm), with a mobile phase composed of acetic buffer 0.1 M pH 2.5/acetonitrile/methanol/THF (85/5/5/5) and UV detection was set at 280 nm. The method shown specificity compare to blank serum specimen with retention time of ciprofloxacin at 1.4 min. Lower limit of quantification (LLOQ) was 0.8 ug/mL with dynamic range up to 10 ug/mL (R=0.999). Precision of the method was very good with coefficient of variance (CV) 1.55; 1.78 and 1.04% for concentration at 0.8, 5, 10 ug/mL, respectively. Accuracy of the method was determined by measuring the recovery and shown average recovery of 86.28 and 104.33% for concentration of ciprofloxacin 5 and 10 ug/mL respectively. The method was also shown reliable result on stability test on freezing-thawing, shortterm and long-term stability as well as post preparation stability. Validation result shown that the methods was ready to be used for ciprofloxacin BE testing with Indonesian subject. |
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