Reference Standards Based on the Grosheimin and Cynaropicrin

Abstract

The aim of this work is the development of effective method for producing the reference standards of Grosheimin and Cynaropicrin for quality control of domestic herbal medicines, as well as project development concerning normative documents on reference standards of Grosheimin and Cynaropicrin, an introduction of reference standards to the Pharmacopoeia of Kazakhstan. This article discusses the method of allocation and purification of reference standards of Grosheimin and Cynaropicrin which are sesquiterpene lactones of guaiane type were obtained from the ethyl acetate extract of <em>Chartolepis intermedia</em> Boiss., using centrifugal distribution chromatography and high performance liquid chromatography, allows to obtain the qualitative target products. The effectiveness of developed technology has reduced the labor contribution in 2.0 times and as a consequence the prime cost of end products come down 3 times. Using of Grosheimin and Cynaropicrin as own<br />reference standard of the Republic of Kazakhstan for monitoring of staged quality control of pharmaceutical production: access control, intermediate control and output control, it means the finished dosage form. There are some chromatographic analysis data of the samples. Such methods as IR and NMR- spectophotometries were applied for determination of molecular structure. Pharmacopoeial methods were used to determine the color, taste, odor and solubility of reference standards in various solvents. Projects for temporary Analytical Normative Documents on reference standards of Grosheimin and Cynaropicrin were developed in accordance with requirement of State Pharmacopeia of the Republic of Kazakhstan. On the basis of obtained results the database for State Pharmacopoeia of the Republic of Kazakhstan will be formed, as well as control over production of new pharmaceuticals from <em>Chartolepis intermedia</em> Boiss. and <em>Saussurea salsa</em> (Pall.) Spreng.