尿素软膏的质量研究

Study on Quality Specification for Urea Ointment

摘要: 目的建立尿素软膏的定性定量方法。方法采用TLC对该制剂中尿素成分进行定性鉴别；采用高效液相色谱法测定尿素的含量。色谱柱为Ultimate XB-NH₂柱(4.6 mm×200 mm，5 μm)，流动相为乙腈-甲醇-水(10%磷酸调pH至3.6) (90∶7∶3)；检测波长：200 nm；柱温：30 ℃；流速：0.8 mL·min^-1；进样量：20 μL。结果尿素TLC定性鉴别专属性强；尿素进样量在2~40 μg内呈良好的线性关系(r=0.999 5)，平均回收率为98.8%(n=9)。结论本方法定性专属性强，定量准确可靠，方法简便易行，灵敏度高，适用于尿素软膏的质量控制。

Abstract: OBJECTIVE To establish the quality and quantity methods of urea ointment. METHODS Urea in urea ointment was identified by TLC. The sample was purified with XB-NH₂ column and its content was determined with HPLC. The XB-NH2 column(4.6 mm×200 mm, 5 μm) was used and mobile phase was acetonitrile-methanol-water(90∶7∶3, adjusted to pH 3.6 with 10% phosphoric acid). The detection wavelength was 200 nm, and the flow rate was 0.8 mL·min^-1. RESULTS Within the range of 2-40 μg, peak area and urea injection quantity were in linear(r=0.999 5), and the average recovery was 99.9%(n=9). CONCLUSION The method is specific, effect, sensitive and accurate. It can be used for quality control of urea ointment.