高效液相色谱法测定异烟肼片中异烟肼及其杂质的含量

目的建立测定异烟肼片剂中异烟肼及其杂质含量的高效液相色谱（HPLC）法。方法色谱柱为Shim-PackVP-OD柱（150mm×4．6mm，5μm），流动相为甲醇-0．2％多库酯钠水溶液（40：60），流速为0．8mL／min，紫外检测波长为216nm。结果异烟肼质量浓度在10～1000mg／L范围内与峰面积线性关系良好（r=0．9998，n=6），平均回收率为99．19％，RSD=1．99％（n=6）；异烟酸质量浓度在4～24mg／L范围内与峰面积呈良好线性关系（r=0．9994，n=6）。结论该法快速、简便、准确、重现性好。

Determination of Isoniazid and Its Impurity in Isoniazid Tablet by HPLC

Objective To establish a HPLC method for determining the contents of isoniazid and its impurity in Isoniazid Tablets. Methods The analytical column was SHIM-PACK VP-ODS and the mobile phase was methanol-water（0. 2% docusate sodium,40 ： 60） at the flow rate of 0.8 mL/min. The UV detection wavelength was 216 nm. Results In the range of 10 - 1 000 mg/L,the contents of isoniazid had good linear relationship with their peak area（ r =0. 999 8, n =6）. The average recovery rate was 99. 19%, RSD = 1.99% （n =6）. And in the range of 4- 24 mg/L,the contents of isonicotinic acid had good linear relationship with their peak area（ r =0. 999 4, n =6）. Conclusion The method is rapid, simple and accurate with good reproducibility.