国际药学与生命科学研究与发展杂志

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SPECTROPHOTOMETRIC VALIDATION METHOD OF DEXCHLORPHENIRAMINE MALEAT AND BETAMETHASONE

Resmi Mustarichie, Jutti Levitaa, Ida Musfiroha

This paper have a purpose to determine the condition of analysis of betamethasone and dexchlorpheniramine maleat on tablet using ultraviolet spectrophotometry and high perfomance liquid chromatography (HPLC) methods. The spectrophotometry method used phosphate buffer pH 7,2 as the solvent, whereas the HPLC method used HPLC, LC-10AT VP, Shimadzu;μ BondapakTM C18 10μm 125Å, 4,6 x 150 mm coloumn Waters (Irlandia); methanol buffer (45:55) pH 7,2 as mobile phase; ultraviolet detection 240 nm; flow rate 1 mL/menit. Result showed that the correlation coefficient of spectrophotometry were 0,9998 and 0,9997 for dexchlorpheniramine maleat dan betamethasone at wavelength 239 and 262. The LOD for spectrophotometry were 2,261 ppm for dexchlorpheniramine maleat at λ 239 ; 0,707 ppm for dexchlorpheniramine maleat at λ 262 ; 0,088 ppm for betamethasone at λ 239 ; dan 0,127 for betamethasone at λ 262, the LOQ were 7,536 ppm for dexchlorpheniramine maleat at λ 239 ; 2,357 ppm for dexchlorpheniramine maleat at λ 262 ; 0,295 for betamethasone at λ 239 ; dan 0,425 for betamethasone at λ 262. The recovery percentation of the spectrophotometry methods for dexchlorpheniramine maleat and betamethasone were 101,32% and 100,77%. The recovery percentation of the HPLC methods for dexchlorpheniramine maleat and betamethasone were 107,6% and 100,8%. Coefficient of variance of the spectrophotometry methods methods for dexchlorpheniramine maleat and betamethasone were 1,413 % and 0,466 %, coeffisien of variance of the robustness test of the spectrophotometry methods for dexchlorpheniramine maleat and betamethasone were 0,834 % and 1,140 %. Based on this research has been found that the the analysis method of spectrophotometry was eligible for the validation parameter value. These data may be applied in Pharmaceutical industries.