Development and validation of new RP-HPLC method for the determination of gliclazide in tablet dosage form
A new sensitive and economic analytical method for the analysis of gliclazide in tablet dosage form was developed and validated using commercial HPLC instrument with modern ultra-performance liquid chromatography column. Samples were analysed using Agilent 1100 Series RP-HPLC equipped with a binary pump and auto injector. Samples were injected into Xselect HSS C18 XP column (2.1 × 100 mm, 2.5 μm), 2.5 μm) and the phase consisted of triethylamine buffer 0.3% (pH = 3 adjusted using phosphoric acid) and acetonitrile in the ratio of 50:50 v/v. The flow rate was 0.4 mL/min and the DAD detector was used for the detection and the wavelength was 229 nm. The method was validated according to ICH guidelines. The retention time for gliclazide peak was 3.437 ± 0.41 min with the total run time of 6 min with total solvent consumption of 2.4 mL per run. The method was found linear over the range 0.1-10 μg/mL with coefficient of determination R2 of 0.9997. The recovery was 98.09-100.19 %, and the method showed high precision and repeatability. Degradation pathway of gliclazide was studied following different types of stress degradation which are base, acid, UV, and oxidization. All validated parameters were in the acceptable range of ICH requirements. In conclusion, a new, rapid, sensitive, and economic method was developed and validated for the analysis of gliclazide in tablet dosage form. ? 2017, Colegio de Farmaceuticos de la Provincia de Buenos Aires. All rights reserved.
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XSelect HSS C18 Column, , 100?, 3.5 µm, 1 mm X 150 mm, 1/pkg
186006378
XSelect HSS C18 Column, 100?, 3.5 µm, 3 mm X 30 mm, 1/pkg
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XSelect HSS C18 Column, 100?, 3.5 µm, 3 mm X 50 mm, 1/pkg
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XSelect HSS C18 Column, 100?, 3.5 µm, 4.6 mm X 100 mm, 1/pkg
186004767
XSelect HSS C18 Column, 100?, 3.5 µm, 4.6 mm X 150 mm, 1/pkg
186004768
XSelect HSS C18 Column, 100?, 5 µm, 2.1 mm X 100 mm, 1/pkg
186006392
XSelect HSS C18 Column, 100?, 5 µm, 2.1 mm X 50 mm, 1/pkg
186006391
XSelect HSS C18 Column, 100?, 5 µm, 2.1 mm X 150 mm, 1/pkg
186006393
XSelect HSS C18 Column, 100?, 3.5 µm, 3 mm X 75 mm, 1/pkg
186005642
XSelect HSS C18 Column, , 100?, 5 µm, 2.1 mm X 30 mm, 1/pkg
186006390
XSelect HSS C18 Column, 100?, 3.5 µm, 1 mm X 50 mm, 1/pkg
186006376
XSelect HSS C18 Column, 100?, 3.5 µm, 1 mm X 100 mm, 1/pkg
186006377
XSelect HSS C18 Column, 100?, 5 µm, 3 mm X 150 mm, 1/pkg
186006398
XSelect HSS C18 Column, 100?, 3.5 µm, 3 mm X 150 mm, 1/pkg
186004763
XSelect HSS C18 Column, 100?, 5 µm, 3 mm X 100 mm, 1/pkg
186006397
XSelect HSS C18 Column, 100?, 3.5 µm, 3 mm X 100 mm, 1/pkg
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XSelect HSS C18 Column, 100?, 5 µm, 2.1 mm X 150 mm, 3/pkg
186006411
XSelect HSS C18 Column, 100?, 3.5 µm, 2.1 mm X 100 mm, 1/pkg
186006383
XSelect HSS C18 Column, 100?, 3.5 µm, 2.1 mm X 75 mm, 1/pkg
186006382
XSelect HSS C18 Column, 100?, 3.5 µm, 2.1 mm X 50 mm, 1/pkg
186006381
XSelect HSS C18 Column, 100?, 3.5 µm, 2.1 mm X 30 mm, 1/pkg
186006380
XSelect HSS C18 Column, 100?, 3.5 µm, 4.6 mm X 75 mm, 1/pkg
186006387
XSelect HSS C18 Column, 100?, 3.5 µm, 4.6 mm X 50 mm, 1/pkg
186004772
XSelect HSS C18 Column, 100?, 3.5 µm, 4.6 mm X 30 mm, 1/pkg
186004771
XSelect HSS C18 Column, 100?, 3.5 µm, 2.1 mm X 150 mm, 1/pkg
186006384
XSelect HSS C18 Column, 100?, 3.5 µm, 4.6 mm X 250 mm, 1/pkg
186004770
XSelect HSS C18 Column, 100?, 5 µm, 4.6 mm X 100 mm, 1/pkg
186006403
XSelect HSS C18 Method Validation Kit, 100?, 3.5 µm, 4.6 mm X 100 mm, 3/pkg
186006409
XSelect HSS C18 Method Validation Kit, 100?, 2.5 µm, 2.1 mm X 50 mm, 3/pkg
186006251
XSelect HSS C18 Method Validation Kit, 100?, 2.5 µm, 2.1 mm X 150 mm, 3/pkg
186006794
XSelect HSS C18 Column, 100?, 5 µm, 4.6 mm X 30 mm, 1/pkg
186006401
XSelect HSS C18 Column, 100?, 5 µm, 4.6 mm X 75 mm, 1/pkg
186006402
XSelect HSS C18 Method Validation Kit, 100?, 2.5 µm, 3 mm X 150 mm, 3/pkg
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XSelect HSS C18 Intelligent Speed (IS) Column, 100?, 5 µm, 4.6 mm X 20 mm, 1/pkg
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XSelect HSS C18 Method Validation Kit, 100?, 2.5 µm, 4.6 mm X 150 mm, 3/pkg
186006796
XSelect HSS C18 Column, 100?, 5 µm, 3 mm X 250 mm, 1/pkg
186006399
XSelect HSS C18 Column, 100?, 5 µm, 3 mm X 50 mm, 1/pkg
186006396
XSelect HSS C18 Column, XP Column, 100?, 2.5 µm, 3 mm X 30 mm, 3/pkg
176002622
XSelect HSS C18 Intelligent Speed (IS) Column, 100?, 3.5 µm, 2.1 mm X 20 mm, 1/pkg
186006379
XSelect HSS C18 Column, 100?, 5 µm, 4.6 mm X 50 mm, 1/pkg
186004852
XSelect HSS C18 Column, 100?, 5 µm, 4.6 mm X 250 mm, 1/pkg
186004775
XSelect HSS C18 Method Validation Kit, 100?, 3.5 µm, 4.6 mm X 150 mm, 3/pkg
186006410
XSelect HSS C18 Method Validation Kit, 100?, 5 µm, 4.6 mm, X 250 mm, , 3/pkg
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XSelect HSS C18 Method Validation Kit, 100?, 5 µm, 4.6 mm X 100 mm, 3/pkg
186006414
XSelect HSS C18 Method Validation Kit, 100?, 5 µm, 4.6 mm X 150 mm, 3/pkg
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XSelect HSS C18 Column, 100?, 5 µm, 4.6 mm X 150 mm, 1/pkg