USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN
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...
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| Format: | Article |
| Language: | English |
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Department of Chemistry, Universitas Gadjah Mada
2010-06-01
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| Series: | Indonesian Journal of Chemistry |
| Online Access: | https://jurnal.ugm.ac.id/ijc/article/view/21494 |
| _version_ | 1819140730804764672 |
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| author | Tri Joko Raharjo Tri Wahyudi Sismindari Sismindari |
| author_facet | Tri Joko Raharjo Tri Wahyudi Sismindari Sismindari |
| author_sort | Tri Joko Raharjo |
| collection | DOAJ |
| description | 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 bio-analytical method for certain drug target and group of population. This research report specific validation of bio-analysis of Rifampicin 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 RP 18 column (250 × 4.6 mm i.d., 5 µm), with a mobile phase composed of KH2PO4 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 µg/mL with dynamic range up to 20 µg/mL (R>0.990). Precision of the method was very good with coefficient of variance (CV) 0.58; 7.40 and 5.56% for concentration at 0.06, 5, 15 µg/mL, respectively. Accuracies of the method were 3.22; 1.94; 1.90% for concentration 0.06, 5 and 15 µg/mL respectively. The average recoveries were 97.82, 95.50 and 97.31% for concentration of rifampicin 1, 5 and 5 µg/mL, respectively. The method was also shown reliable result on stability test on freezing-thawing, short-term and long-term stability as well as post preparation stability. Validation result shown that the method was ready to be used for Rifampicin BE testing with Indonesian subject.
Keywords: Rifampicin, Validation, USFDA-Guideline |
| first_indexed | 2024-12-22T11:43:12Z |
| format | Article |
| id | doaj.art-966b37e23dc54bfdb37142070e347888 |
| institution | Directory Open Access Journal |
| issn | 1411-9420 2460-1578 |
| language | English |
| last_indexed | 2024-12-22T11:43:12Z |
| publishDate | 2010-06-01 |
| publisher | Department of Chemistry, Universitas Gadjah Mada |
| record_format | Article |
| series | Indonesian Journal of Chemistry |
| spelling | doaj.art-966b37e23dc54bfdb37142070e3478882022-12-21T18:27:13ZengDepartment of Chemistry, Universitas Gadjah MadaIndonesian Journal of Chemistry1411-94202460-15782010-06-0110113814110.22146/ijc.2149414592USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMENTri Joko Raharjo0Tri Wahyudi1Sismindari Sismindari2Department of Chemistry, Faculty of Mathematics and Natural Sciences, Universitas Gadjah Mada, Sekip Utara, Yogyakarta 55281Faculty of Pharmacy, Universitas Gadjah Mada, Sekip Utara Yogyakarta 55281Faculty of Pharmacy, Universitas Gadjah Mada, Sekip Utara Yogyakarta 55281; Integrated Laboratory for Testing and Research (LPPT-UGM), Universitas Gadjah Mada, Sekip Utara Yogyakarta 55281Regarding 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 bio-analytical method for certain drug target and group of population. This research report specific validation of bio-analysis of Rifampicin 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 RP 18 column (250 × 4.6 mm i.d., 5 µm), with a mobile phase composed of KH2PO4 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 µg/mL with dynamic range up to 20 µg/mL (R>0.990). Precision of the method was very good with coefficient of variance (CV) 0.58; 7.40 and 5.56% for concentration at 0.06, 5, 15 µg/mL, respectively. Accuracies of the method were 3.22; 1.94; 1.90% for concentration 0.06, 5 and 15 µg/mL respectively. The average recoveries were 97.82, 95.50 and 97.31% for concentration of rifampicin 1, 5 and 5 µg/mL, respectively. The method was also shown reliable result on stability test on freezing-thawing, short-term and long-term stability as well as post preparation stability. Validation result shown that the method was ready to be used for Rifampicin BE testing with Indonesian subject. Keywords: Rifampicin, Validation, USFDA-Guidelinehttps://jurnal.ugm.ac.id/ijc/article/view/21494 |
| spellingShingle | Tri Joko Raharjo Tri Wahyudi Sismindari Sismindari USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN Indonesian Journal of Chemistry |
| title | USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN |
| title_full | USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN |
| title_fullStr | USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN |
| title_full_unstemmed | USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN |
| title_short | USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN |
| title_sort | usfda guideline based validation of testing method for rifampicin in indonesian serum specimen |
| url | https://jurnal.ugm.ac.id/ijc/article/view/21494 |
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