RESUMO
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.
RESUMO
BACKGROUND: Chemometric can be defined as a branch of analytical chemistry using statistical principles to design and select optimal analytical procedures and experiments. The chemometric technique that applies in the design of quantitative calibration curves in the spectral analysis is very important in quality control of the component contained in the drug mixture of 2 or 3 drug components or more, especially the component that has the adjacent wavelength when the spectrum overlap. AIM: The purpose of this study was to conduct research that examines betamethasone and neomycin mixture in cream with the UV spectrophotometric methods using a chemometric calculation. METHODS: Chemometric calculation for determination of betamethasone and neomycin mixture in cream supply by ultraviolet spectrophotometric. RESULTS: The result of betamethasone and neomycin levels were 91.35% and 97.56%, relative standard deviation (RSD) for betamethasone and neomycin 0.93%; 1.73% and recovery percentage 99.09%; 99.94%. On the multivariate calibration of PLS betamethasone and neomycin with each RMSEC value of 0.0230 and 0.3553 with the value of RMSECV 0.7187 and 0.3586 with RMSEP value 0.1558 and 0.0820. Thus, the predictive ability of the research is still acceptable and is well used for grade determination of betamethasone and neomycin content fulfil the requirement for cream preparation according to USP edition XXX. CONCLUSION: Methods of UV spectrophotometric with chemometric can be used in the determination of BET and NEO levels in cream preparations and BET level is 91.35% with a range of 90-110%, and NEO level is 97.56% with a range of 94.45-98.71%. These levels have met the requirements of the levels listed in Indonesian Pharmacopoeia, 2014.
RESUMO
PURPOSE: To determine the effect of phacoemulsification on macular volume and thickness using spectral domain optical coherence tomography examinations. METHODS: Twenty-seven eyes of 27 subjects who underwent phacoemulsification were studied. All nine areas of the macula were examined by spectral domain optical coherence tomography preoperatively and 2 months postoperatively. Effective phacoemulsification time and absolute phacoemulsification time were also recorded. RESULTS: There were statistically significant differences in macular thickness between preoperative and postoperative spectral domain optical coherence tomography examinations in nine areas including macular volume. In the paracentral macular area, the thickness of three quadrants significantly increased (superior P=0.015; temporal P=0.001; and nasal P=0.023). Peripheral macular thickness also increased significantly in the superior (P=0.05) and temporal macular areas (P<0.001). The macular volume increased significantly after phacoemulsification (P<0.001). There were no correlations between absolute/effective phacoemulsification time and macular cellular structures (P>0.05), but a significant correlation (P=0.011) was found between absolute phacoemulsification time and change in macular volume. CONCLUSION: Macular thickness changes in the nasal, superior, and temporal quadrants of the paracentral area and the superior and temporal quadrants of the peripheral area, as well as macular volume, may be used as detailed biomarkers to measure the effects of intraocular pressure fluctuations and maneuvers in phacoemulsification intraocular surgeries.
