Abstract
This study describes the development and validation of an isocratic HPLC method for the stability of gliclazide assay in the presence of metformin hydrochloride (MET) in pharmaceutical dosage forms using ion pair - reversed phase liquid chromatographic technique. The ion pairing agent used in this study is tetrabutyl ammonium hydrogen sulphate (TBHS). The TBHS 0.030 molar solution in water was adjusted to pH 6.0 with 1 N sodium hydroxide solution and was used as buffer. The composition of the buffer and acetonitrile used was 40:60 (v/v) on reverse phased column, bonded with octadecyl silane, while the wave length used was 225 nm. As such, the drug gave a linear response (r2>0.999). The method was found to be selective, precise, accurate and robust, and can be used for quality control assay of the bulk and finished dosage form as a single dose in combination with metformin hydrochloride. Key words: Ion pair, reversed phase, UV detection, gliclazide.
Highlights
Gliclazide is chemically known as 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl)-3-[(4-methylphenyl) sulfonyl] urea
This study describes the development and validation of an isocratic HPLC method for the stability of gliclazide assay in the presence of metformin hydrochloride (MET) in pharmaceutical dosage forms using ion pair - reversed phase liquid chromatographic technique
Separation between metformin hydrochloride and gliclazide was observed using various other mobile phases and different organic modifiers, but the degraded product of gliclazide and metformin hydrochloride interfered with gliclazide peak
Summary
Gliclazide is chemically known as 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl)-3-[(4-methylphenyl) sulfonyl] urea. This study describes the development and validation of an isocratic HPLC method for the stability of gliclazide assay in the presence of metformin hydrochloride (MET) in pharmaceutical dosage forms using ion pair - reversed phase liquid chromatographic technique. The method was found to be selective, precise, accurate and robust, and can be used for quality control assay of the bulk and finished dosage form as a single dose in combination with metformin hydrochloride.
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