Analytical procurement of pharmaceutical development of preparation with thioctic acid in the form of injectable solution

Abstract

Aim: The aim of this study is to carry out analytical supplying of pharmaceutical development and standardization of methods of quality control of the drug with thioctic acid (α-TA) by the main indices in accordance with the requirements of the State Pharmacopoeia of Ukraine (harmonized with the European Pharmacopoeia) for parenteral medicinal products, namely, injectable solutions. Materials and Methods: The analytical research has been conducted by the method of liquid chromatography on the chromatograph of the firm “Waters 2487” (USA); thin-layer chromatography (TLC) method; method of potentiometry on рН-meter “МР-512” using electronic scales “Sartorius BA 210S;” and measuring dishes of А class. Results and Discussion: The analytical procurement of pharmaceutical development and standardized methods of quality control according to the main indices in accordance with the requirements of the State Pharmacopoeia of Ukraine for parenteral medicinal products (solutions for infusions) has been created to develop a combined original drug for the treatment of critical states of different etiologies. The validation of the method of identification and quantitative determination of α-ТА in the final dosage form, using the liquid chromatography method for analytical supplying of pharmaceutical development, has been developed, standardized, and validated. The validation studies performed for the test “quantitative determination” confirm the concordance of such validation characteristics as the forecast of complete uncertainty of the analysis, specificity, linearity, precision, and eligibility criteria. The method developed can be proposed for the determination of α-ТА identification and the concomitant impurities (admixture A and other non-specific impurities) in the injectable solution simultaneously with the quantitative determination of α-ТА. The determining method of the identification of auxiliary substance trometamol by TLC has been tested. The suitability of the method for determining the impurity B (polymerase α-ТА) in the injectable solution by the TLC method has been developed and proved. Conclusion: The method of identifying the subsidiary substance trometamol together with the active substance by TLC method is presented. The applicability of the method for determining the impurity B (thioric acid polymerase) in a solution for injection by TLC has been developed and proved.