Suitability System of Microbiological Method for Nystatin Potency Determination in the Routine Analysis Using Agar Diffusion Method

Abstract

Nystatin is a polyene macrolide antifungal active which is used for the treatment of candidiasis and obtained from some species of Streptomycesbacteria. The present work describes the statistical suitability analysis for regular monitoring of the agar diffusion bioassay in a simple, inexpensive and time-saving process before potency determination. A balanced (symmetrical) two-dose parallel line assay model was applied using the agar well diffusion method for quantification of Nystatin in raw material and finished medicinal dosage form. The routine inspection methodology yielded good results and included calculations by the linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). The assay is based on the inhibitory effect of Nystatin upon a standard strain as described in the United States Pharmacopeia (USP). The results of the post validation regular assays were treated statistically by ANOVA and the deviations (expressed as average ± standard deviation) from both raw and column totals were 0.702 ± 0.476 and 0.865 ± 0.468, respectively. The mean value of the variance ratio for regression and parallelism squares were 534.349 ± 212.546 and 0.596 ± 0.345, respectively. The study of Nystatin's ongoing analysis showed that the microbiological assay design is satisfactory with respect to the limiting values for the determination of the potency. The established balanced parallel line assay is reasonably stable and suitable and can be used for the regular drug analysis in routine quality control testing and the quantitation of Nystatin in pharmaceutical dosage form and raw material. Doi: 10.28991/SciMedJ-2021-0304-2 Full Text: PDF

Keywords

• nystatin
• parallel line assay
• quality control
• agar diffusion
• regression
• parallelism.