以逆相高效能液相層析法分析市售藥品 Olanzapine之藥物含量

本論文應用高壓液相層析儀來檢測定量臨床精神分裂用藥olanzapine之含量，以建立最簡易，快速且高準確性之分析方法來做為藥品之檢測依據。管柱Vercopak C18 [250 × 4.6 mm (id), 5 µm] 為固定相；移動相為磷酸鹽緩衝溶液(20 mM NaH2PO4； pH = 6.8) / (甲醇/乙腈 = 1/1) = (30/70，V/V)，波長為254 nm 與流速為1.0 mL/min為檢測之分析條件，進行條件分析確效試驗。結果，線性濃度範圍 6 ~ 16 µg/ml (r = 0.99990)，精密性之可重覆性濃度10 ?慊/mL RSD = 0.4% (n = 5)，中間精密度不同天RSD = 0.4% (n = 18)；不同人RSD = 0.2% (n = 12)；不同機RSD = 0.2% (n = 12)，回收率為100.3% ~ 101.3%。分析方法的耐變性試驗，變更流速± 0.2 mL/min；pH± 0.2及流動相± 5%。分析確效之結果驗證，此法具有高準確性及靈敏度且具有專一性，能夠有效檢測市售藥品內之olanzapine含量。

關鍵字

逆相高效能液相層析法；精神分裂用藥；精神分裂症

並列摘要

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.