The quantitative analysis methods validation of Paeonia Anomala L. Tincture / Монголын эм зүй, эм судлал

ABSTRACT

Introduction@#The development of analytical methods for evaluation of quality standard parameters of drugs and other health prophylactic, diagnostic, and therapeutic products is essential from the beginning in the process to release to the market finished product. Validation of developed analytical methods is one crucial part of the analysis.</br> Quantitative determination methods of the total main active compounds of the tincture prepared from the root and the herb of <i>Paeonia anomala</i> L. were developed. In order to verify whether the analytical procedure is suitable for its intended purpose parameters – accuracy, reproducibility, intermediate precision, and linearity were validated.@*Materials and methods@#The total phenolics in the tincture were determined by the reaction with Folin Chicolteau reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively. Based on the achieved results of the developed quantitative methods which were validated according to the accepted and pursued technical documents in our country the Eurachem guide “The Fitness for Purpose of Analytical Methods” and Russian Pharmacopoeia 13 “Validation of analytical methodology”, where parameters as accuracy, precision – reproducibility, intermediate precision, and linearity are involved.@*Conclusions@#Statistical analysis of total phenolic compounds and total monoterpene glycosides in the <i>Paeonia anomala</i> tincture demonstrated that the bias calculated was for accuracy 0.674% and 0.703%, relative standard deviations were for reproducibility 0.896% and 0.798%, for inter- mediate precision 0.922% and 0.696%, respectively and the linearity – R²=0.9985 and R²=0.9997. All achieved results validated the appropriateness of the developed quantitative methods for the intended purpose.