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應用HPLC方法測定Cefadroxil原料藥及其製劑之力價

Determination of Cefadroxil Preparations by High Performance Liquid Chromatography

摘要


本研究旨在發展出一套簡單、迅捷且具特異性之高效液相層析法,以應用於鑒別及測定Cefadroxil之原料藥及其製劑(包括膠囊、口服懸液用粉劑)之力價:本法所使用之層析管為μ-Bondapak(上標 TM)C18,並以Acetonitrile和0.1M磷酸鹽緩衝溶液(60:40)之混合液為移動相,Dimethylphthalate為內部對照標準品,而於254nm波長處以紫外光偵測器測之。於本實驗中當Cefadroxil濃度範圍為0.02-0.8mg/ml時,所求得之標準白線(Standard curve)線性迴歸方程式為X=0.0881298Y-0.0000289,相關係數r=0.9999。本法所能偵測之最低限量為25ng。添加不同量之Cefadroxil於市售檢體(膠囊、口服懸液用粉劑)中,所得的平均回收率約在100.56%以上。重覆注射同一濃度之Cefadroxil標準品溶液,所測得Within-day之精確度為0.48%, 0.36%, 0.45%, 0.64%, 0.65%, 0.47%; Between-day之精確度為0.71%,顯示本法再現性(Reproducibility)極高。 為得知本HPLC法是否可取代微生物法測定Cefadroxil製劑之力價,Cefadroxil各製劑同時以二種方法作配對實驗測定力價,並用Pairedt test作配對比較。結果發現,於99%可信度範圍(Confidence level)內,原料藥、膠囊、口服懸液用粉劑同時以二種方法測定所得之力價並不具統計之差異。亦即HPLC法似可用以取代微生物法測定Cefadroxil原料藥及市售各製劑之力價。

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並列摘要


A reverse-phase liquid chromatographic method was developed for the assay of cefadroxil in bulk drug and pharmaceutical preparations. The samples were analyzed on a μBondapak (C18) column with a mobile phase of acetonitrile and 0.01M potassium phosphate at a flowrate of 1.0ml/mm and UV absorbance detection at 254nm. Equation was presented for linear relationship between peak area ratios of cefadroxil to dimethylphathalate (internal standard) and the cefadroxil concentration over a range of 0.02-0.8mg/mi (r=0.999). The detection limit was 25ng. Standard addition recoveries ranged from 97.89% to 101.44% (mean 99.92%, n=18) for capsules and from 99.38% to 105.85% (mean 102.86%, n=5) for powders for oral solution. Both the within-day precision (C. V. of 0.36% to 0.65%) and the between-day precision (C. V. 0.71%) were satisfactory. Furthermore, different formulations from, fifteen manufactures were also assayed by the two analytical methods. At the 99% confidence level, no significant intermethod differences were noted for the assay results for each pair. The results indicated that the reverse-phase liquid chromatographic method is a suitable substitute for the microbiological method for potency assays of cefadroxil preparations.

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