RESUMO
BACKGROUND: Irbesartan and hydrochlorothiazide are a group of anti-hypertensive drugs that are very effective and safe to use to reduce blood pressure and oedema. The combination has a small active ingredient content so that if the treatment didn't meet the requirements for therapeutic doses, it not achieved to the maximum therapy. AIM: The research aims to the simultaneous determination of irbesartan and hydrochlorothiazide in tablets by Ratio subtraction spectrophotometry method. METHODS: The absorption spectra and sample measurement in the Ratio subtraction method performed on Irbesartan at a wavelength of 247.6 nm and 273.6 nm for the Hydrochlorothiazide (HCT) using 0.1 N NaOH as a solution. This method is validated with linearity, accuracy, and precision in intraday and interday, LOD and LOQ and applied in the determination of a mixture of irbesartan and hydrochlorothiazide in the dosage tablet. RESULTS: The validation test for IRB is 101.03 for accuracy, with a precision of 0.57; with precision testing at intraday 0.34 and interday 1.34, and LOD is 0.70 and LOQ is 2.12. Meanwhile, validation for HCT that the accuracy 100.34%; precision 0.89 and precision on intraday 1.20 and interday 1.18, and LOD 0.78 and LOQ 2.37 with IRB levels are 101.03 ± 0.63% and HCT is 100.59 ± 0.91%. CONCLUSION: The ultraviolet spectrophotometric method in subtraction ratio method was validated a method of linearity, accuracy, precision in intraday and interday, LOD, and LOQ and according to ICH guidelines and successfully applied for the determination simultaneous of irbesartan and hydrochlorothiazide in the tablet's dosage form.
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.
