Determination of esters and amides of aminobenzoic acid in the composition of finished dosage forms with acidic monoazo-dye tropaeolin O

  • M. Ya. Smolinska State Scientific-research Control Institute of Veterinary Medicinal Products and Feed Additives, Lviv
  • I. Ya. Kotsiumbas State Scientific-research Control Institute of Veterinary Medicinal Products and Feed Additives, Lviv
  • G. Y. Teslyar State Scientific-research Control Institute of Veterinary Medicinal Products and Feed Additives, Lviv
  • M. V. Yurkevych State Scientific-research Control Institute of Veterinary Medicinal Products and Feed Additives, Lviv
  • M. B. Smeyko State Scientific-research Control Institute of Veterinary Medicinal Products and Feed Additives, Lviv
Keywords: spectrophotometry, local anesthetics, azocoupling, Tropaeolin О, finished dosage forms

Abstract

Esters of aminobenzoic acid are widely used in medical practice as effective painkillers of local action, and its amide as is an antiarhythmic drug. The peculiarity of these drugs, in terms of analytical control, is a low content of active ingredients. It requires sufficiently sensitive methods for their quality control. Usually in these cases the HPLC method are used, which are relatively expensive and demand quite high qualification of an operator; while the spectrophotometric method is much cheaper, more accessible, more rapid, and moreover, it can be used as a routine method in analytical laboratories.

The aim of this work was to study the interaction of p-aminobenzoic acid and its amide (procainamide), three esters (benzocaine, procaine, oxybuprocaine) and one ester of m-aminobenzoic acid (proxymetacaine) with azo-dye tropaeoline O to develop new spectrophotometric method of their determination in various dosage forms with satisfactory validation parameters.

It was established that diazo salts of primary aromatic amines react with tropaeoline O to form the coloured product with the maximum absorbance at 595 nm, while the dye does not absorb the light at this wavelength. The conditions of diazo salts amines interaction with azo dye are as follows: the reaction takes place in the medium of 0,01 M sodium tetraborate at pH 10–11 at 2-fold excess of tropaeoline O. Also the method of these amines spectrophotometric determination has been elaborated. The method possesses a wide linearity range, viz. from 0,4 to 20,0 mg/ml depending on the detectable amine.

The content of procaine, procainamide, oxybuprocaine and proxymetacaine in pharmaceutical medicines was determined. The results are consistent with the content of amines by the manufacturer, as well as with the results obtained by nitritometric titration.

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Published
2019-02-12
How to Cite
Smolinska, M. Y., Kotsiumbas, I. Y., Teslyar, G. Y., Yurkevych, M. V., & Smeyko, M. B. (2019). Determination of esters and amides of aminobenzoic acid in the composition of finished dosage forms with acidic monoazo-dye tropaeolin O. Farmatsevtychnyi Zhurnal, (2), 59-68. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/245
Section
Production, quality control, standardization of medicines