Baeza FAN, Díaz ÁEE, Martínez ACN

Language: Spanish
References: 13
Page: 29-39
PDF size: 103.52 Kb.

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 μg/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, hydrochlorothia zide, 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 μg/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 crosscontamination of glibenclamide and other drugs already described.

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