Author(s): NIE Honglei, ZHANG Danlu, NIE Lei, ZANG Hengchang, ZENG Yingzi
Pages: 386-389
Year: 2016 Issue:  7
Journal: Qilu Pharmaceutical Affairs
Keyword:  Shenzhiling Oral Solution; HPLC; Fingerprint; Quality estimation;
Abstract: Objective To establish the fingerprint and quantitative analysis of Shenzhiling Oral Solution by HPLC,and provide reasonable reference for its quality evaluation and control. Methods The Waters Sunfire C18 column(4. 6 mm × 250 mm,5 μm)was used and the detection wavelength was set at 254 nm. The column temperature was 30 ℃ . The mobile phase was composed of acetonitrile and 0. 1% phosphoric acid aqueous solution eluting in a liner gradient mode at the flow rate of 1. 0 mL·min - 1 . Results In the 13 batches of Shenzhiling Oral Solution,cinnamic acid peak was employed as a reference,and 19 common peaks were found. The similarity between samples in validity period was within 0. 964 ~ 0. 988, while the samples beyond validity period had relatively lower similarity(0. 814 ~ 0. 933),suggesting distinct difference could occur in chemical components of samples. Conclusion The established method was strong pertinence and could be used as an effective method for the quality control of Shenzhiling Oral Solution.