扎来普隆含量测定方法的研究

Study on assay of zaleplon

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WatersSpherisorbS5ODS2 (5μm ,4 6mm× 2 5 0mm)分析柱 ,流动相为甲醇 0 0 1mol·L-1磷酸溶液 (5 7∶4 3) ,流速 1 0mL·min-1,柱温为 2 5℃ ,检测波长为 2 31nm。结果 方法的精密度和稳定性均良好 ;扎来普隆浓度在 0 0 113～ 0 0 6 75mg·mL-1内 ,峰面积与浓度呈良好的线性关系 (r=0 9998) ,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。

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 (5 μm, 4.6 mm × 250 mm) column. The mobile phase was a mixture of methanol -0.01 mol&middotL-1 phosphoric acid (57:43) and the flow rate was 1.0 mL&middotmin-1, and column temperature 25°C, 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&middotmL-1 to 0.067 5 mg&middotmL -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.