目的 应用高效液相色谱-二极管阵列检测(HPLC-DAD)技术,建立阿卡波糖片中阿卡波糖的含量测定方法。方法 采用Alltima C18色谱柱(4.6 mm×250 mm,5 μm),以乙腈-10 mmol·L-1磷酸二氢铵溶液(含0.04%辛烷磺酸钠,磷酸调至pH 3.3)(15∶85)为流动相,流速0.8 mL·min-1,检测波长200 nm,柱温30 ℃。结果 在本方法中,阿卡波糖的线性关系良好,线性相关系数(r)为1.000 0;专属性强,阿卡波糖和药品中其他成分以及强制降解产物之间均有良好的分离度;精密度和稳定性良好,RSD分别为0.088%和0.22%;回收率良好,3个加样浓度的平均回收率(n=9)为98.49%,RSD为0.24%。对4批阿卡波糖片进行测定,含量分别为每片51.69、51.75、51.72、51.62 mg。结论 该方法准确、简单、快速,可作为阿卡波糖片中阿卡波糖的含量测定方法。
Abstract
OBJECTIVE To develop an high-performance liquid chromatography (HPLC) method with diode array detector (DAD) for determination of acarbose in acarbose tablets. METHODS An Alltima C18 column (4.6 mm×250 mm,5 μm) was used for the separation, with acetonitrile-10 mmol·L-1 ammonium dihydrogen phosphate (containing 0.04% sodium 1-octanesulfonate, adjusted pH to 3.3 with H3PO4) (15∶85) as the mobile phase at the flow rate of 0.8 mL·min-1. The detection wavelength was set at 200 nm and the column temperature was maintained at 30 ℃. RESULTS The method showed good linearity with a correlation coefficients (r) of 1.000 0. The specificity study demonstrated satisfactory resolutions between acarbose, other ingredients in the drug and forced degradation products. The precision and stability were satisfactory with the relative standard deviations (RSDs) of 0.088% and 0.22%, respectively. The average spiked recovery was 98.49% with RSD of 0.24% (n=9). The content of acarbose in four batches of acarbose tablets was 51.69, 51.75, 51.72 and 51.62 mg·tablet-1, respectively. CONCLUSION The established method is accurate, simple and rapid, and can be utilized for determination of acarbose in acarbose tablets.
关键词
高效液相色谱-二极管阵列检测 /
阿卡波糖片 /
阿卡波糖 /
含量测定
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Key words
HPLC-DAD /
Acarbose tablets /
acarbose /
determination
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中图分类号：
R917
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