HPLC法测定升脉康颗粒中人参皂苷Rg_1的含量

目的建立升脉康颗粒中人参皂苷Rg1含量的测定方法。方法甲醇提取,蒸干,加水溶解,水饱和的正丁醇萃取,正丁醇液以2%氢氧化钠溶液碱洗及水洗后蒸干,甲醇溶解后进样测定。采用高效液相色谱法(HPLC),十八烷基硅烷键合硅胶为填充剂;乙腈-水(23:77)为流动相;检测波长203 nm。理论塔板数按人参皂苷Rg1峰计算应不低于3000。结果通过方法学的系统考察和三批样品的含量测定,建立了本制剂中人参皂苷Rg1的含测方法。人参皂苷Rg1在0.096~0.960 mg.mL-1范围内峰面积与其浓度呈良好的线性关系。回归方程Y=5 964 600X+160 410,r=1.0。测得三批样品的含量范围为4.951~5.398 mg袋/,平均回收率为97.8%,变异系数RSD为1.36%。结论本法灵敏度高,重现性好,专属性强,是控制本品内在质量的较理想含测方法。

Determination of ginsenoside Rg1 in Shengmaikang Granules by HPLC

OBJECTIVE To establish a method for the determination of ginsenoside Rg1 in Shengmaikang Granules by HPLC. METHODS Using methanol extraction and evaporation to dryness, water soluble, extracted by n - butanol of water saturated and then was evaporation to dryness after alkali washing by 2% sodium hydroxide solution and water washing. Then the sampie was determined after dissolved by methanol. The HPLC method used octadecyl silane chemically bonded silica as bulking agent, acetonitrile-water （ 23：77 ） as the mobile phase. The detection wavelength was 203 nm. The number of theoretical plates calculated by ginsenoside Rg1 peak should not be less than 3 000. RESULTS Established the method for the determination of ginsenoside Rgl in this praeparatum through technology consideration and determination of three batches of samples. Ginsenoside Rg1 in 0. 096 ~ 0. 960 mg . mL-1 within the peak area was observed with a good linear relations. The regression equation was Y = 5 964 600 X ＋ 160 410, r = 1.0. The content range of three batches of samples was 4. 951 -5. 398 mg/bag. The average recovery was 97. 8% and the RSD was 1.36%. CONCLUSION The method was sensitive, reproducible, specific, and was suitable to control the intrinsic quality of the product.