USFDA-GUIDELINEBASED VALIDATION OF TESTING METHODFOR RIFAMPICIN IN INDONESIANSERUM SPECIMEN
ABSTRACT Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugs should show 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 admin...
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| Format: | Article NonPeerReviewed |
| Published: |
[Yogyakarta] : Universitas Gadjah Mada
2010
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| Online Access: | https://repository.ugm.ac.id/28070/ http://i-lib.ugm.ac.id/jurnal/download.php?dataId=11133 |
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| Institution: | Universitas Gadjah Mada |
| Summary: | ABSTRACT
Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugs should show
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 Rifampicin in Indonesian serum specimen in or.der to be used for BE testing. The extraction was
performed using acetonitrile while the chromatographic separation was accomplished on a RP 18 column
(250 x 4.6 mm i.d., 5.J.lm),with a mobile phase composed of KH2P04 10 mM-Acetonitrile (40:60, v/v) and UV
detection was set at 333 nm. The method shown specificity compared to blank serum specimen with retention time
of rifampicin at 2.1 min. Lower limit of quantification (LLOQ) was 0.06 J.lg/mLwith dynamic range up to 20 J.lg/mL
(R>0.990). Precision of the method was very good with coefficient of variance (CV) 0.58 |
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