HPLC法测定复方胃蛋白酶颗粒中维生素B_1的含量及含量均匀度

Determination of the content and content uniformity of Vitamin B_1 in compound saccarated pepsin granules by HPLC

目的:建立HPLC法测定复方胃蛋白酶颗粒中维生素B_1的含量及含量均匀度。方法:色谱柱为Thermo BDS HYPERSIL C_(18)(4.6 mm×150 mm,5μm),流动相为甲醇-乙腈-0.02 mol·L^(-1)庚烷磺酸钠溶液(含1%三乙胺)(用磷酸调节pH值为3.7)(10∶10∶80),检测波长为260 nm,柱温30℃,流速1.0 m L·min^(-1)。结果:维生素B_1进样量在25.4~634.1 ng范围内线性关系良好(r=0.999 9),平均回收率为100.1%,RSD为1.12%(n=9)。维生素B_1含量测定结果为:83.4%;含量均匀度测定结果为:各厂家A+2.2S均大于15.0。结论:方法快速准确,灵敏度高,重现性好,结果可靠,为复方胃蛋白酶颗粒的质量控制提供依据。

Objective： To establish a method for determination of the content and content uniformity of Vitamin B1 in Compound Saccarated Pepsin Granules by HPLC. Methods： The test was performed in Thermo BDS HYPERSIL C_（18）（ 4. 6 × 150 mm,5 μm） column with methanol-aceonitrile -0. 02 mol·L^-1 sodium heptanesulfonate solution（ containing 1% triethylamine and adjusting pH to 3. 7 with phosphoric acid）（ 10∶ 10∶ 80） as the mobile phase.The flow rate was 1. 0 mL·min^-1,the detection wavelength was 260 nm,and the column temperature was 30 ℃.Results： The calibration curves of Vitamin B1 showed the good linearity in the range of 25. 4-634. 1 ng（ r = 0. 9999）. The average recovery was 100. 1% with RSD as 1. 12%（ n = 9）. The average content of Vitamin B1 was 83. 4%. The average of A ＋ 2. 2 S of each company samples were greater than 15. 0. Conclusion： The established method is rapid,accurate and reliable,and it has the good sensitivity and reproducibility. It can provide the reference for the quality control of Compound Saccarated Pepsin Granules.