PENGEMBANGAN KAEDAH ANALISIS YANG SENSITIKDAN SPESIFIK BAGI PENENTUAN PIRONARIDINA DAN APLlKASINYA DI DALAM KAJIAN KLINlKAL
| dc.contributor.author | M. KARUPIAH, SUNDRAM | |
| dc.date.accessioned | 2015-12-28T02:45:59Z | |
| dc.date.available | 2015-12-28T02:45:59Z | |
| dc.date.issued | 2003-05 | |
| dc.description.abstract | Pyronaridine is a promising antimalarial drug for the treatment of P. Jalciparum malaria which is resistant to chloroquine. Thin layer chromatography (TLC) and high perfonnance liquid chromatographic (HPLC) method with fluorescence detection have been developed to analyse pyronaridine and its related compounds in pyronaridine raw material. Chromatographic separation for TLC was carried out using benzene : methanol: dietylamine (80:20:1 v/v). With respect to HPLC method, chromatographic separation was performed on. a reversed phase C18, Partisil 10, ODS 3 column (250 x 4.6 mm) at room temperature (27°C) with methanol and acetate buffer (0.05M, pH 4) (50:50 v/v) as the mobile phas~. Flow rate of the mobile phase was 1.2 mllmin. Fluorescence detection was used and Aex and Aem were set at 267 nm and 443 nm respectively. The analysis of raw samples using HPLC and TLC shows 3 peaks (namely B, X and Y) and 3 spots respectively. Column chromatography was then used to isolate B and Y after refluxing pyronaridine raw materials in water. Infra red, mass spectrometry and nuclear magnetic resonance analysis indicated that Y is pyronaridine. Compound Y was then used as the standard to prepare calibration curves for the detennination of pyronaridine in biological fluids using solid phase extraction. The overall recoveries from plasma for pyronaridine and quinidine (internal standard) were 95.2 and 82.3 % respectively. The assay procedure was adequately sensitive to measure 5 ng/ml pyronaridine in plasma samples with acceptable precision «10% CV). The validated analytical method was used to detennine pyronaridine in clinical samples from five Thai patients with uncomplicated falciparum malaria. All patients received 12 mglkg pyronaridine daily for three days via the oral dose. The maximum concentration (Cmax) and time to reach maximum concentration (T max) were 119.6 ± 36.4 ng/ml and 80.0 ± 79.9 hr respectively. The elimination half life, clearance, area under curve (AUCooGl) and volume of distribution were 194.0 ± 47.8 hr, 77.3 ± 5.5 ml/minlkg, 29450 ± 13082 ng.hr/ml and 4.7 ± 0.8 Llkg, respectively. The method was found to be suitable for use in clinical phannacological studies. | en_US |
| dc.identifier.uri | http://hdl.handle.net/123456789/1347 | |
| dc.subject | PIRONARIDINA | en_US |
| dc.subject | KAJIAN KLINlKAL | en_US |
| dc.title | PENGEMBANGAN KAEDAH ANALISIS YANG SENSITIKDAN SPESIFIK BAGI PENENTUAN PIRONARIDINA DAN APLlKASINYA DI DALAM KAJIAN KLINlKAL | en_US |
| dc.type | Thesis | en_US |
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