DEVELOPMENT AND VALIDATION OFQUANTITATIVE IODOMETRICTITRATION METHOD OF“PROTOPLASMA”, 10% SOLUTION OFINJECTION
Today, in huge numbers of the products presented in thepharmaceutical market, one of the major position have theproducts with heterocyclic ring, 80% of which are syntheticmolecules. It is interesting that among heterocyclic ringsPyridine maintains a leading position and is well used.“Protoplasma”, 10% Solution of Injection, is the innova-tion product of the company “Biotex Ltd”. Because of itsheterogeneous content, it was important to reveal and deter-mine the substance or sum of the substances, the content ofwhich can be considered as a main specific compound forquantitative determination in Assay.Therefore, the aim of our study was the selection of thesubstance, method of analysis and its validation.According to modern requirements, the analysis of theproducts should be carried out only by validated methods.Based on conducted studies was developed and validat-ed quantitative Iodometric Titration Method of “Protoplas-ma”, 10% Solution of Injection by dimethylpiridine concen-tration. The process is linear in concertation frames 0.80-1.07%, correlation coefficient r2=0.99959 and variation coef-ficient %CV=1.07%.The given validation parameters give us opportunity todeclare that method has high precision and the concentra-tion of dimethylpiridine in the object can be determined withhigh accuracy.