Validation and Simultaneous Estimation of Betamethasone Valerate and Neomycin Sulfate Cream by Absorbance Ratio Spectrophotometry Methods

Abstract

Absorbance ratio is a method that has been developed in the simultaneous determination of UV spectrophotometry. There are no research reports on this method on simultaneous estimation of betamethasone valerate and neomycin sulfate mixture in cream preparations. Therefore, this study aims to develop and validate the absorbance ratio method for the simultaneous estimation of betamethasone valerate and neomycin sulfate mixture in cream preparations with 70% ethanol as a solvent and at the intersection of wavelength 245 nm. The result showed that the regression equation for BTS is Y = 0.04039 X + 0.00349 and the regression equation for neomycin sulfate is Y = 0.00254 X + 0.00165 with validation tests were LOD was 0.645 µg/mL, LOQ was 2.15 µg/mL, accuracy was 100.07%, precision was 0.87% for betamethasone valerate and LOD was 2.215 µg/mL, LOQ was 7.385 µg/mL, accuracy was 100.68%, precision was 0.82% for neomycin sulfate. Levels of BTS was 111.1 ± 0.97% and levels for neomycin sulfate was 100.91 ± 0.37%. The proposed method has met ICH guidelines and can be used for simultaneous estimation of betamethasone valerate and neomycin sulfate in cream form.

Validation and Simultaneous Estimation of Betamethasone Valerate and Neomycin Sulfate Cream by Absorbance Ratio Spectrophotometry Methods

“…The wavelength where the intersection of the two curves is the absorption point of both solutions [7][8][9] . METHOD VALIDATION [10][11][12][13] The absorbance ratio technique used in this study were all validated based on validation methods required by ICH guidelines 11 .…”

“…Aliquots of BTV and NES standard solutions each pipetted carefully, each transferred into two groups of 50 mL measuring flask and added ethanol solvent to obtain the concentration range of 5.6-20.5µg/mL for BTV and 85-340µg/mL for NES [12][13] .…”

“…Based on the obtained curve, a linear relationship is achieved if the values of b = 0 and r = +1 or -1 depending on the direction of the line. While the value of a indicates the sensitivity of the analysis, especially the instruments used [11][12][13] .…”

Chemometric Calculation for Determination of Betamethasone and Neomycin Mixture in Cream Supply by Ultraviolet Spectrophotometry

“…Besides that, this technique is successfully applied to all analytical methods in spectrophotometry [4]. Spectrophotometry ratio absorbance and area under the curve are two valid modified to quantify BET and NEO in cream [5], [6].…”