Validation of High-Performance Chromatography method to quantify Nystatin in ointment

León J.R.H.; Chinen L.K.; Delgado D.Q.; Joaquin J.W.S. · Revista Cubana de Medicina Militar (2024)

Resumen

Introduction: Nystatin is an antifungal drug widely used to treat oral candidiasis, a common infection in the mouth caused by the fungus Cándida. In the development of pharmaceutical products, it is essential to use a specific analytical method that allows the precise quantification of the active ingredient present in the formulation. Objective: To validate an analytical method using high performance liquid chromatography for the quantification of nystatin in ointment. Methods: This is an applied research with a quantitative approach. The technique used for the validation of the analytical method is high-performance liquid chromatography. Analysis of the following parameters is included: specificity, accuracy and precision. Statistical tools were used to analyze the results, highlighting data analysis, coefficient of variation and statistical comparison. Results: The validation parameters evaluated confirmed their specificity, for which no interferences were found in the analysis. The accuracy of 98.83% with C.V. of 0.48%. The intermediate precision with coefficient of variation (C.V.) (%) ≤ 2 %. It is determined that the proposed method is suitable for the quantification of Nystatin ointment. Conclusions: The validated method for the active pharmaceutical ingredient nystatin can be applied in quality control due to its specificity, precision and linearity within the concentration range studied. By using this new method, accurate results are obtained that do not differ statistically from those obtained by the established US Pharmacopeia method.

Instituciones: Universidad María Auxiliadora