Gliclazide is a sulfonylurea oral antidiabetic drug. It is a white crystalline or crystalline powder, odorless and tasteless.
Gliclazide is a 2nd generation oral sulfonylurea hypoglycemic agent with strong action. Its mechanism is similar to that of toluenosulfonylurea, i.e., it selectively acts on pancreatic β-cells to promote insulin secretion and enhance insulin release after eating glucose, which can not only improve the metabolism of diabetic patients, but also improve or delay the occurrence of diabetic vascular complications.
Gliclazide is mainly used for mild and moderate type II diabetes mellitus with adult onset where diet and exercise control alone are ineffective and without a tendency to ketosis, and also improves fundus lesions and metabolic and vascular dysfunctions in diabetic patients.
Gliclazide is used for control of hyperglycemia in gliclazide-responsive diabetes mellitus of stable, mild, non-ketosis prone, type 2 diabetes. It is used when diabetes cannot be controlled by proper dietary management and exercise or when insulin therapy is not appropriate. National Kidney Foundation claims that Gliclazide does not require dosage uptitration even in end stage kidney disease.
|Test||Specifications||Results of analysis|
|Appearance||White or almost white powder.||White powder|
|Solubility||Practically insoluble in water; freely soluble in methylene chloride; sparingly soluble in acetone; slightly soluble in ethanol(96 per cent).||Meets the requirements|
|Identifications||The infrared absorption spectrum is concordant with that obtained with gliclazide CRS.||Meets the requirements|
|Impurity B (By HPLC)||≤2ppm||0.5ppm|
|Related substances (By HPLC)||Impurity F ≤0.1%||Non-detected|
|Each unspecified impurity ≤0.10%||0.04%|
|Sum of impurities other than F ≤0.2%||0.11%|
|Loss on drying||≤0.25%||0.11%|
|Residual solvents (By GC)||Ethyl acetate NMT 2500 ppm||265ppm|
|N,N-Dimethylformamide NMT 880 ppm||Non-detected|
|Assay||99.0-101.0%, on dried basis.||100.0%|
|Conclusion||The test results conform with EP8.|