Development and validation of the spectrophotometric method for the determination of sodium sulfacetamide in eye drops
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Keywords

sodium sulfacetamide, 3-α,γ-dycarboxypropilrhodanine, spectrophotometry, validation

Abstract

The conditions and chemistry of the reaction of sodium sulfacetamide with 3-α,γ-dicarboxypropilrhodanine were studied and the method of  spectrophotometric determination of sodium sulfacetamide in «Sulfacil» eye drops was developed on this basis and validated.
Reagents and solvents used in the present study: a standard sample of sodium sulfacetamide, «Sulfacil 200 mg/mL» and «Sulfacil 300 mg/mL», 3-α,γ-dycarboxypropilrhodanine (chemically pure), sodium nitrite and sodium phosphate solutions were prepared by accurately weighed extra pure reagents dissolving, hydrochloric acid solutions were prepared by the extra pure acid concentrated solution diluting.
Analytical equipment: Spectrophotometer SF-46, electronic weighing scale RADWAG WPA 40/160/C/1, laboratory glassware of class A.
The technique of spectrophotometric determination of sodium sulfacetamide quantitative content in «Sulfacil» eye drops based on its reaction with 3-α,γ-dycarboxypropilrhodanine was developed. The stoichiometric ratio of the reactive components as 1:1 was obtained by the methods of continuous
changes and the saturation method. The technique validation allowed confirming its linear fit, high precision, accuracy and robustness which proved the possibility of its application in quality control departments of chemical and pharmaceutical industry companies.
Thus, the interaction reaction between the preliminary diazotized sodium sulfacetamide with 3-α,γ-dycarboxypropilrhodanine was investigated which resulted in a colored azo compound obtaining. Quantitative spectrophotometric technique was developed for sodium sulfacetamide determination in
«Sulfacil» eye drops based on this reaction. The developed technique was validated according to such validation characteristics as the linear fit correspondence, range of applicability, precision, correctness and robustness.

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