扎来普隆含量测定方法的研究

 目的 建立测定原料及胶囊中扎来普隆含量的方法。方法 用高效液相色谱法，色谱柱为Waters Spherisorb S5 ODS2(5 μm,4.6 mm×250 mm)分析柱，流动相为甲醇-0.01 mol·L^-1磷酸溶液（57∶43），流速1.0mL·min^-1，柱温为25℃，检测波长为231 nm。结果 方法的精密度和稳定性均良好；扎来普隆浓度在0.011?3～0.067 5 mg·mL^-1内，峰面积与浓度呈良好的线性关系（r=0.999?8），平均回收率为99.7%；扎来普隆与其相邻杂质峰的分离度符合要求。结论 方法简便、专属、重现性好，可用于扎来普隆原料及其它制剂的含量测定。

Study on assay of zaleplon

OBJECTIVE To develop a method for the determination of zaleplon in its pharmaceutical material and preparation METHODS A RP-HPLC method was used with Waters Spherisorb S5 ODS2 (5μm, 4.6 mm×250 mm) column. The mobile phase was a mixture of methanol -0.01 mol·L^-1 phosphoric acid (57∶43) and the flow rate was 1.0 mL·min^-1, and column temperature 25℃, with the detection wavelength at 231 nm RESULTS The precision and stability were fine. The linear correlation was observed from the concentrations of 0.011 3 mg·mL^-1 to 0.067 5 mg·mL^-1 (r=0.999 8). The average recovery was 99.7%. Resolution between zaleplon peak and other peaks met the requirements CONCLUSION The method was convenient, selective and reproducible.