Development of procaine hydrochloride and sulfanilamide assay methods in compounding ointment
DOI:
https://doi.org/10.15587/2519-4852.2017.104401Keywords:
compounding ointments, spectroscopy, Procaine hydrochloride, SulfanilamideAbstract
In the modern pharmaceutical market there is a tendency to compounding revival and expansion. Due to this fact, there is a need to develop of modern methods for quality control and stability testing for the given group of drugs. Since most dosage forms are multicomponent, it is necessary to consider the influence of active pharmaceutical ingredients on analysis.
Aim. The aim of research was development of the methods for Procaine hydrochloride and Sulfanilamide determination in the milticomponent ointment on the basis of produced 3% tetracycline ointment with the further use of the developed methods for the remedy stability testing.
Methods. Spectroscopy method was used for Procaine hydrochloride determination, and “Primary aromatic amines determination” method was used for Sulfanilamide analysis.
Results. Due to impossibility of separation of Procaine hydrochloride and Sulfanilamide during sample preparation, it was necessary to develop a method for determination of one of them. For Procaine hydrochloride quantitative determination spectroscopy method at wavelength of 522 nm after formation of associate with methyl orange was offered. To eliminate the other components influence on Procaine hydrochloride absorption, other substances and their mixtures spectra were studied. The linearity of Procaine hydrochloride in the range of application of 80-120% of the nominal concentration in the dosage form was studied. All linear dependence criteria do not exceed the allowable values according to the State Pharmacopoeia of Ukraine requirements.
For Sulfanilamide analysis, Primary aromatic amines determination” method according to the State Pharmacopoeia of Ukraine is recommended, taking into account the estimated amount of titrant spent on Procaine hydrochloride titration.
Conclusion. Spectroscopy method for Procaine hydrochloride quantitative determination and titration method for Sulfanilamide analysis were developed. Statistical criteria of the obtained results of the both methods were calculated. The relative error for Procaine hydrochloride was 1.1 %, and it was 1.39 for Sulfanilamide; these indexes do not exceed the allowable values which allow recommending the offered methods for the ointment analysis and stability testingReferences
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Copyright (c) 2017 Valentin Vrakin, Ivan Bezruk, Lesia Savchenko, Anna Materienko, Victoria Georgiyants
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