Determination Of Amphotericin B In Bulk And Pharmaceutical Formulation By Spectrophotometer.
[摘要] Nowadays the methods available for determination of Amphotericin B are costly. Till date there is noeconomic and reproducible spectrometric method for quality control of Amphotericin B in bulk andpharmaceutical dosage has been reported. To develop economic, accurate, reproducible and validatedspectrometric method for quality control of pharmaceutical formulations containing Amphotericin B.Spectrometric method was used for estimation of Amphotericin B using Dimethyl sulfoxide [DMSO] and Water1:1 as a solvent. On basis of absorption of visible light, Amphotercin B spectra in DMSO and Water 1:1 ratioshowed maximum absorption wavelength (Lambda max) at 415 nanometer [nm]. The calibration curve wasplotted and linear over the concentration range from 2-20µg/ml of Amphotericin B with correlation coefficient0.9975. Validation was performed as per International Council of Harmonization [ICH] guidelines for linearity,accuracy, precision; recovery and results were within required limits. LOD and LOQ found to be 0.0570 and0.1574 respectively by simple UV spectroscopy. This method has Percent Relative standard deviation [% RSD]less than one and reproducible. From the results the developed method proves to be valid, sensitive and linearover the concentration range studied and applicable for quality control, routine analysis and determination ofAmphotericin B in Bulk and pharmaceutical dosage form.
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[效力级别] [学科分类] 工程和技术(综合)
[关键词] Amphotericin B;spectrophotometric method;ICH guidelines. [时效性]