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ABSTRACT:
A selective, precise and accurate RP-HPLC method was developed and validated for rapidly determining the quantity of gliclazide in pharmaceutical dosage form. Isocratic elution was employed on a PhenomenexC18 column at a flow rate of 1.2 ml/min. The mobile phase consisted of methanol and 0.02 M potassium dihydrogen orthophosphate (70:30 %v/v). Gliclazide was detected at 210 nm wavelength using UV detector. Linearity was observed in concentration range of 1-100 pg/ml. Retention time of gliclazide retention time was found to be 6.06 min. Validation of developed method was performed as per the ICH guideline. Experimental design approach was used for confirmation of robustness by using Box-Behnken Design with a total 17 runs. The newer method is found to be promising for the estimation of gliclazide in unit or bulk pharmaceutical dosage form.
KEYWORDS: Gliclazide, RP-HPLC, validation, Box-Behnken Design, Robustness.
(ProQuest: ... denotes formulae omitted.)
INTRODUCTION:
Diabetes mellitus is a foremost health problem and a vital cause of prolonged ill health and early death. Many anti-diabetic drugs with different mechanisms of action are now available for treatment of type 2 diabetes mellitus. Sulfonylureas have been extensively used for treatment of type 2 diabetes1. Gliclazide, glipizide, glibenclamide and glimepiride are second-generation sulfonylureas, currently used, while first-generation drugs (such as tolbutamide and chlorpropamide) are no longer used. Second-generation drugs are equally effective in lowering blood glucose concentrations1. Gliclazide is a potent hypoglycaemic agent which compares favourably with others of its type. It has a low incidence of side effects, few problems with hypoglycaemia, and retains its efficacy longer than other sulphonylureas. Gliclazide may therefore be considered a first choice for the therapy of type II diabetes mellitus2.
It also selectively inhit pancreatic K+ ATP channels, antioxidant activity and other beneficial haemobiological effects3. Figure 1 shows that gliclazide is chemically [1-(3-azabicyclo(3,3,0)oct-3-yl)-3ptolylsulfonylurea]. It is mainly used in the non-insulin dependent diabetes mellitus (NIDDM) treatment. It is second generation hypoglycemic sulfonylurea4. It activates the beta cells of the Islet of Lengerhans in the pancreas to release insulin. It increases peripheral insulin sensitivity. Overall it potentiates insulin release and improves insulin dynamics5.
Literature survey revealed that gliclazide has been estimated by analytical methods such as spectrophotometry6, HPTLC and HPLC7-10. HPLC has also been used for combination containing gliclazide.
The application...