Establishment and validation of quantitative analysis of multi-components by single-marker for quality assessment of compound danshen preparations

Abstract

Summary.Compound danshen preparations (CDPs) are used clinically for the treatment of cardiovascular and cerebrovascular diseases. By using the quantitative analysis of multi-components by single-marker (QAMS) method, sixteen compounds (danshensu, protocatechuic acid, protocatechuicaldehyde, caffeic acid, rosmarinic acid, lithospermic acid, notoginsenoside R1, salvianolic acid B, ginsenoside Rg1, ginsenoside Re, salvianolic acid A, salvianolic acid C, ginsenoside Rb1, ginsenoside Rd, cryptotanshinone, and tanshinone IIA were quantified on an ACQUITY ultraperformance liquid chromatography (UPLC) HSS T3 column (2.1 × 100 mm, 1.8 μm) with the mobile phase consisting of 0.1% formic acid aqueous solution (A) and acetonitrile (B) using a gradient elution at the flow rate of 0.30 mL/min in 30 min at 30°C, which was also validated by UPLC-diode array detection (DAD) and UPLC-electrospray ionization multistage/mass spectrometry (ESI-MS/MS) for assuring the feasibility and accuracy. Tested by robustness experiment under slightly changeable conditions, the stability of relative correction factor (RCF) proved to be stable, with RSDs below 5.69%, except for notoginsenoside R1 with relative standard deviation (RSD) 7.83%. This reliable and convenient QAMS method resolved the problem of standard substance insufficiency and improved the quality assessment of preparations consisting of complex compounds with different chemical structures, such as CDPs.

Determination of 4 Nucleosides via One Reference Compound in Chinese Cordyceps by HPLC-UV at Equal Absorption Wavelength

“…[8][9][10] The newly developed HPLC process only required 1 reference compound, it was both reference compound-saving and costeffective. Compared with the QAMS, [14][15][16] the QAMS requires establishing the RCF for determining other components, increasing operational complexity. Furthermore, the RCFs for different detecting wavelengths were different, 20,21 limiting its wide application.…”

“…[8][9][10] In order to reduce the cost of reference compounds in herbal medicine analysis the quantitative analysis of multicomponents by single marker method (QAMS) was developed. [14][15][16] The adenosine was used as a standard substance to establish the relative calibration factors (RCF) between itself and other nucleosides, and the simultaneous determination of nucleosides in the Chinese cordyceps sample was carried out by adenosine with the RCF. However, the reported QAMS method needed the RCF to determinate other nucleosides, which increased the operational complexity.…”

Advances and challenges in ginseng research from 2011 to 2020: the phytochemistry, quality control, metabolism, and biosynthesis

“…Multiple reaction monitoring (MRM) or selective reaction monitoring (SRM) has become the most commonly used strategy for multi-ginsenoside quantitation by monitoring the transition of ion pair(s), 35,[210][211][212][213][214][215][216][217][218][219][220][221] while those giving rare fragments by MS/MS fragmentation can be determined using selective ion monitoring (SIM), 222 which were exclusively completed on triple quadruple mass spectrometers. On-line MRM/SIM switching can be achieved on the Agilent 6410 triple quadrupole mass spectrometer for the simultaneous quantitative assay of 15 ginsenosides from P. ginseng.…”

“…A total of 25 CPMs containing P. ginseng , red ginseng, P. quinquefolius , and(or) P. notoginseng , were qualitatively and/or quantitatively analyzed, with the information detailed in Table S6 † 306–326 . HPLC, 318,321,322 HPLC/IT-MS, 189,309,323 HPLC/QQQ-MS, 214,219 HPLC/QTOF-MS, 216,306,312,317 HPLc/QTrap-MS, 307,320 HPLC/LTQ-Orbitrap-MS, 190 UHPLC, 184,310 UHPLC/LTQ-Orbitrap-MS, 315 UHPLC/QQQ-MS, 216,220 UHPLC/QTOF-MS, 199,201,308,311,319 NIRS, 316 and NMR, 325 were utilized.…”

“…CPMs that contain P. notoginseng are diverse, such as Xuesaitong Injection, 323 Xinkeshu Capsule/Tablet/Pill, 191 Xueshuantong Injection, 271,319 Compound Xueshuantong Capsule, 209,320 Yanghuo Sanqi Tablet, 321 Shuxiong Tablet, 326 Sanqi Panax Notoginseng Injection, 322 Compound Danshen preparations, 220,325 Naoluo Xintong Decoction, 324 and Qishen Yiqi Dropping Pill. 221 The fingerprint profiles of 10 batches of Xuesaitong Injection were analyzed, which showed 27 characteristic saponins.…”