| Summary: | 碩士 === 高雄醫學大學 === 醫學研究所 === 101 === In this thesis, the high-performance liquid chromatography, a broadly used instrument for drug analysis was applied to establish a fast, accurate and efficient method for the analysis of the marketed olanzapine, a clinical drug for schizophrenia.
A Vercopak C18 [250 × 4.6 mm (id)] column was used as stationary phase and the mixture of (20 mM NaH2PO4；pH = 6.8) / (methanol/acetonitrile = 1/1) = (30/70，V/V) was utilized as mobile phase. The UV detection (254 nm) and flow rate of the mobile phase (1.0 mL/min) were performed. The resulting assay exhibited a linear range of 6 ~ 16 μg/mL (r = 0.99990), a relative standard deviation of 0.4% (n = 5) for the precision of repeated injections of 10 ?慊/mL, a relative standard deviation of 0.4%(n = 18) for different days intermediate precision, a relative standard deviation of 0.2%(n = 12) for different persons, a relative standard deviation of 0.2%(n = 12) for different instruements and a recovery of 100.3% ~ 101.3%. For a robustness testing of the analytical method, flow rate ± 0.2 mL/min, pH ± 0.2 and the composition of mobile phase (± 5% were studied. From experimental results, our analytical method was proved to exhibit the advantages of accuracy, precision and specificity. Thus, the quantitative analysis of the marketed olanzapine was established.
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