臺灣博碩士論文加值系統

　　本研究係發展一個快速、簡單且可信賴的HPLC分析方法，來檢測市售藥品中泛酸鈣的含量。市售藥品以Alltech Alltima C18 (250×4.6mm I. D.)為分離管柱、移動相溶液為acetonitrile potassium dihydrogen phosphate (KH2PO4)，酸鹼值以以磷酸調至 2.5 ，流速為1.0ml/min、紫外光吸收波長為204nm來偵測之。以ampicillin 當作內標準品。此系統的線性範圍為10~50 □g/ml，線性關係系數為0.9999。12種市售品的標準添加回收率皆大於98.96%。Within-day 的相對差異系數在0.1-0.9%之間，Between -day 的相對差異系數在 0.1-0.7%之間。
　　同一檢品以HPLC法及微生物檢驗法做檢驗，結果再以paired t-test (a=.05) 做比較，發現二種方法之結果並無差異。又由於HPLC的方法所花費的時間少，且可以排除因微生物所產生的不確定因素，且準確度高，故可以HPLC 方法代替微生物檢驗法來檢測市售藥品中泛酸鈣的含量。

　　This report described a fast, simple, reliable HPLC method for the assay and quantitative determination of calcium pantothenate in commercial products. The samples were analyzed on a Alltima (C18) column with the mobile phase of acetonitrile and potassium dihydrogen phosphate solution (adjusted pH to 2.5 with phosphoric acid) at a flow rate of 1.0 ml/min and UV absorbance detection at 204 nm. Ampicillin was used as an internal standard. The system was linear from 10-50 □g/ml (r=0.9999). Standard addition recoveries were greater than 98.96% with twelve commercial products. The relative standard deviations were between 0.1 and 0.9% in the within-day assay, 0.1 and 0.7% in the between-day assay.
　　The results obtained with the HPLC and the microbiological assay were paired at the 95% confidence level. There were no significant differences between two methods. The proposed HPLC method was a suitable substitute for the microbiological method for quantitative assays of calcium pantothenate in commercial products.