Formulation and Quantitative Analysis of Betamethasone Valerate and Neomycin Sulfate Cream by High Performance Liquid Chromatography and Spectrophotometry

Abstract

BACKGROUND: Combination of betamethasone valerate and neomycin sulfate in cream is used to treat the itching, redness, dryness, scaling, inflammation and discomfort of various skin conditions caused by infection. The combination of active ingredients has side effects which can cause dry skin, thinning of the skin, hypertrichosis, and stretch marks.
 AIM: The purpose of this study was to make a formula containing vitamin E and quantitative analysis of betamethasone valerate and neomycin sulfate in creams using High Performance Liquid Chromatography and Spectrophotometry Area Under Curve methods.
 METHODS: Cream preparation includes smelting and emulsification processes, with oil phases namely stearic acid and vitamin E as well as water phases are glycerin, sodium bi-borate, tri-ethanolamine. Physical tests for the cream were organoleptic, homogeneity, pH, evaluation of dispersion, and viscosity. HPLC analysis for cream was carried out using C18 column, and the mobile phase of methanol: water with comparison optimization beforehand. Spectrophotometry analysis for cream was carried out using application of Area Under Curves methods.
 RESULTS: The formula used was betamethasone valerate 5 mg, neomycin sulfate 25 mg, stearic acid, glycerin, sodium bi-borate, tri-ethanolamine, vitamin E and distilled water. The obtained cream was in the form of semi-solid, odorless, white (colorless), homogeneous, pH 7, the dispersion power of 500 mg cream is 4.0-4.3 cm in diameter and viscosity is 7500 Cps. Analysis of the determination of the levels of the two components was carried out by the HPLC method C-18 column with the mobile phase of methanol: water (90: 10). Betamethasone valerate and neomycin sulfate levels in formulas made HPLC methods were 94.15%, and 136.56%, respectively and using AUC spectrophotometry methods were 107.98% and 94.81%.
 CONCLUSION: Cream that made by new formula with vitamin E shows good result in physical evaluation. HPLC methods with a mobile phase of methanol: water (90:10) was not recommended, while the AUC spectrophotometry method shows the valid result of quantitative analysis of betamethasone valerate and neomycin sulfate in cream.

Quality by design‐engineered reversed‐phase high‐performance liquid chromatography method development and validation for simultaneous estimation of neomycin sulfate and beclomethasone dipropionate in bulk and pharmaceutical dosage form

“…in 2019, the authors reported the quantitative analysis of betamethasone valerate and neomycin sulfate in creams using HPLC. However, the chromatogram exhibited disturbances between the peaks [12]. However, it is worth noting that none of these studies have reported the utilization of the QbD approach.…”