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Cuantificación de glibenclamida en muestras de limpieza de equipos farmacéuticos mediante cromatografía líquida de alta resolución

Keywords: glibenclamide, glyburide, high performance liquid chromatography, validation, cleaning validation, traces, detection limit, quantization limit.

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Abstract:

objective: to submit a selective analytical method for quantization of glibenclamide in cleaning samples of pharmaceutical equipment using high performance liquid chromatography. methods: the mobile phase consisted of an equal mixing of acetonitrile/phosphate buffer kh2po4; with 0.037 mol/l concentration ph 5.25 and flow of 1.5 ml/min, in a nucleosil 100 c8 column. glibenclamide was injected with progesterone as internal standard and using an uv detector= 230 nm results: the method was linear in the 0.4-150 mg/ml concentration interval having a detection and quantization limits of 10 and 40 ng/ml respectively. it was specific to analyte when placebo is present, to degradation products and to other active ingredients. possible interferences with the proposed method was considered for captopril, chlortalidone, dexametasone, diphenhydramin hcl, digoxine, 8-chlortheophylline, diphenhydramina hcl, phenobarbital, haloperidol, hydrochlorothiazide, fumaric acid, ketotifen, metoclopramide hcl, piridoxine hcl, piroxicam, prednisone and nifedipine, on the other hand, ibuprofen, indometacin, trifluoperazine hcl, thioridazine hcl and imipramine were identified as interferences in the procedure at concentration figures close to 10 mg/ml. conclusions: the present method is sensitive, quick and selective for the evaluation of residues of active pharmaceutical principle glibenclamide in tablet production equipment after a swap sampling and it could be potentially used in case of cross-contamination of glibenclamide and other drugs already described.

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