以簡單快速之分光光度計法檢測藥物劑型中的紅黴素   全文下載

Simple and Rapid Spectrophotometric Method for the Analysis of Erythromycin in Pharmaceutical Dosage Forms

本研究主要在發展一種既簡單且快速的分光光度計法，以被測藥物劑型中紅黴素之含量。在波長285及300nm下，分別使用直接紫外光及一級衍生物測量，配合標準添加法，得到令人滿意的結果。在兩項技術中，甲醇作為溶劑使用；碳酸氫二鉀緩衝溶液（pH 8）將紅黴素硬脂酸醯水解為紅黴素。配合標準添加法的直接紫外光及一級衍生物測量，於濃度範圍3-15 mg/mL下，均有良好的線性關係（r2分別為> 0.98 及> 0.99）及準確性（%RSD< 0.65%）。直接紫外光及一級衍生物測量之最低檢測限量（LOD）分別為0.08及1.37 mg/mL，最低定量濃度（LOQ）分別為0.24及4.17 mg/nL。然而，一級衍生物測量較直接紫外光測量顯示更佳的平均回收率（前者對於A牌及B牌的回收率分別為97.6%及106.5%，%RSD < 3.34%；後者對於A牌及B牌的回收率分別為66.03%及43.80%，%RSD高達47.39%）。因此，基於賦形劑會強烈干擾藥物之紫外光吸收的緣故，一級衍生物測量配合標準添加法更值得用在藥物劑型中紅黴素之檢測。

This work aimed to develop a simple and rapid spectrophotometric method for the analysis of erythromycin in pharmaceutical dosage forms. Direct UV and first derivative measurements at the wavelengths of 285 and 300 nm, respectively, in combination with standard addition method gave promising results. In both techniques, methanol was used as a solvent and dibasic potassium phosphate buffer (pH 8) was used to hydrolyze erythromycin stearate to erythromycin. Both the direct UV and first derivative measurements using standard addition method illustrated excellent linearity in the concentration range of 3-15 mg/mL (r2 > 0.98 and > 0.99, respectively) with good precision (%RSD < 0.65%). The limits of detection (LOD) of direct UV and first derivative measurements were 0.08 and 1.37 mg/mL, respectively, and the limits of quantitation (LOQ) were 0.24 and 4.17 mg/ mL, respectively. However, the first derivative measurement showed better % mean recovery (97.6% and 106.5% for brand A and B, respectively, %RSD < 3.34%) than the direct UV measurement (66.03% and 43.80% for brand A and B, respectively, %RSD up to 47.39%). Thus, the first derivative measurement using standard addition method was valuable for analyzing erythromycin in dosage forms, which excipients strongly interfere the UV absorbance of the drug.