Glipizide Tablets
Action and use
Inhibition of ATP-dependent potassium channels (sulfonylurea); treatment of diabetes mellitus.
Definition
Glipizide Tablets contain Glipizide.
Content of glipizide C21H27N5O4S
90.0 to 110.0% of the stated amount.
Identification
Test
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
20 volumes of ethyl acetate, 20 volumes of anhydrous formic acid and 40 volumes of dichloromethane.
In the chromatogram obtained with solution (1);
any spot corresponding to glipizide impurity A is not more intense than the spot in the chromatogram obtained with solution (4) (0.5%);
any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%);
and not more than two such spots are more intense than the spot in the chromatogram obtained with solution (3) (0.2%).
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 15 mg of Glipizide add 30 mL of methanol, heat gently on a water bath whilst shaking, cool and add sufficient methanol to produce 50 mL. Filter and dilute 5 mL of the filtrate to 50 mL with methanol. Measure the absorbance of the resulting solution at the maximum at 274 nm, Appendix II B, using methanol in the reference cell. Calculate the content of C21H27N5O4S taking 237 as the value of A(1%, 1 cm) at the maximum at 274 nm.