IN-PHARMACY QUALITY CONTROL OF INGREDIENTS OF EYE DROPS WITH TETRACAINE

The eye drops under study were a combination of tetracaine, boric acid and zinc sulfate. The use of eye drops is justified by the ability of tetracaine to local surface anesthesia. Boric acid and zinc sulfate provide an antiseptic and astringent effect. In the work of Kovalskaya G.N. et al. [2] noted the demand for pharmacy-made drugs among doctors and patients. Quality control of drugs manufactured in a pharmacy is important, and the development of quality control methods is relevant. The purpose of the study is to develop methods for in-pharmacy quality control of the ingredients of eye drops with tetracaine. The problems of developing sufficiently accurate methods for the qualitative and quantitative determination of the ingredients of the studied combination drug were solved. In the qualitative analysis of the ingredients, a solution of potassium ferrocyanide was used to determine zinc cations. The sulfate ion was detected in a separate sample using its property of forming a white precipitate with a solution of barium chloride. Tetracaine base was detected in a separate sample by the reaction of formation of a nauseating odor of isonitrile when heating the dosage form with a solution of potassium permanganate. Chloride ion was confirmed in a separate sample by the formation of a white curd sediment with a solution of silver nitrate. Boric acid was detected by the formation of ethyl borate. Quantitative determination of tetracaine hydrochloride and boric acid was carried out by the alkalimetry method in total from one sample. Tetracaine was also analyzed argentometrically. The content of boric acid was calculated by the difference in the volumes of titrants. Zinc sulfate was quantitatively determined complexometrically. The results of this study can be proposed for inclusion in regulatory documentation on drug quality control.