Abstract

SUAREZ PEREZ, Yania; GARCIA PULPEIRO, Oscar; DAO THANH, Thuy  and  MISHIG, Munkhzul. Design and validation of a spectrophotometry method used in quality control of a 0,5 % Piroxican jelly. Rev Cubana Farm [online]. 2009, vol.43, n.4, pp.20-30. ISSN 0034-7515.

The 0.5 % jelly Piroxican is a new product in developing phase from "Roberto Escudero Díaz" Laboratory Enterprise. In present paper a UV spectrophotometry method was designed using ethanol chloride acid as solvent and 328 nm as maximal absorption wave length. A simple and fast procedure was established to processing the sample previous to analysis. Subsequently, we applied the validation of it according current regulatory demands. Method was enough specific, linear, precise and exact at the 3.125 to 9.375 µg/mL. Active principle quantification was applied in three batches of developed formula achieving satisfactory results without statistically significant differences according the applied procedure.

Keywords : Piroxican; jelly; spectrophotometry; validation.

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