Pengembangan Kaedah Analisis Yang Sensitif Dan Spesifik Bagi Penentuan Pironaridina Dan Aplikasinya Di Dalam Kajian Klinikal
| dc.contributor.author | M. Karupiah, Sundram | |
| dc.date.accessioned | 2016-11-22T01:47:55Z | |
| dc.date.available | 2016-11-22T01:47:55Z | |
| dc.date.issued | 2003-05 | |
| dc.description.abstract | Pyronaridine is a promising antimalarial drug for the treatment of P. falciparum 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 perfonned on.a reversed phase C18,Partisil 10, ODS 3 column (250 x 4.6 rom) at room temperature (27°C) with methanol and acetate buffer (0.05M, pH 4) (50:50 v/v) as the mobile phase. Flow rate of the mobile phase was 1.2 ml/min. Fluorescence detection was used and A.cx and A.em were set at 267 nm and 443 nm respectively. The analysis ofraw 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 determination 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 nglml pyronaridine in plasma samples with acceptable precision «10% CV). The validated analytical method was used to determine 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 (Tmax) were 119.6 ± 36.4 nglml and " 80.0 ± 79.9 hr respectively. The elimination half life, clearance, area under curve I,: (AUCo~) and volume of distribution were 194,0 ± 47,8 hr, 77.3 ± 5.5 mlIminlkg, 29450 i ± 13082 ng.hr/ml and 4.7 ± 0.8 Llkg, respectively. The method was found to be suitable f i for use in clinical pharmacological studies. | en_US |
| dc.identifier.uri | http://hdl.handle.net/123456789/3151 | |
| dc.subject | Pyronaridine is a promising antimalarial drug for the treatment of | en_US |
| dc.subject | P. falciparum malaria which is resistant to chloroquine. | en_US |
| dc.title | Pengembangan Kaedah Analisis Yang Sensitif Dan Spesifik Bagi Penentuan Pironaridina Dan Aplikasinya Di Dalam Kajian Klinikal | en_US |
| dc.type | Thesis | en_US |
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