用RP-HPLC指纹图谱控制复方丹参滴丸中低波长紫外吸收指纹成分

Low ultraviolet absorption components in compound Danshen dropping pills controlled by RP-HPLC fingerprints

目的采用双定性双定量相似度作为评价指标,建立了复方丹参滴丸(CDDP)中低波长紫外吸收指纹成分的控制方法。方法采用RP-HPLC法以Century SIL C18BDS柱(200 mm×4.6 mm,5μm);以色谱指纹图谱指数F为目标函数优化选择指纹图谱检测条件,确定流动相为水-乙腈低压梯度洗脱,紫外检测波长:203 nm,柱温:(30.00±0.15)℃,进样量:10μL。以双定性双定量相似度法对10批CDDP进行质量评价。结果以人参皂苷Rg1为参照物峰,确定18个共有指纹峰,建立了CDDP低波长紫外吸收指纹成分的HPLC指纹图谱。评价出10批CDDP的双定性双定量相似度均合格,表明此10批样品的低波长紫外吸收指纹成分的数量、分布比例和含量特征是十分相似的,表现出很好的质量均一性。结论本试验证明双定性双定量相似度法可有效控制CDDP中低波长紫外吸收指纹成分。

Objective To establish an authentic quality control method for the low ultraviolet absorption components in compound Danshen dropping pills （CDDP） controlled by RP-HPLC fingerprints using dual qualitative and dual quantitative similarities （DQDQS） as the assessing parameters. Methods Chromatographic fingerprint （CFP） index （F） was used to optimize the CFP conditions. The CFPs were determined by injecting 10μl. sample solution each time on a CenturySIL C18 BINS column （200 min×4. 6 nm, 5μm） with the gradient etution solvent system consisting of water and aeetonitrile, in which the column temperature maintained at （30. 00 ± 0.15）℃ and the signals were acquired at 203 nm. The 10 batches of CDDP were identified using dual qualitative similarities as evaluating parameters, in which the reference fingerprint （RFP） was synthesized by calculating the average model method. Results The CFPs containing 18 co-possessing peaks were obtained when choosing panaxsaponin Rg1 peak as the reference peak. The contents of the 10 batches of CDDP were all qualified in terms of DQDQS. Quality homogenicity and quantity, distribution proportion and content characteristics were quite similar in the low ultraviolet absorption components of the 10 CDDPs. Conclusion The DQDQS method can effectively assess and control the quality of the low ultraviolet absorption components of compound Danshen dropping pills.