» Acarbose is produced by certain strains of Actinoplanes utahensis. It contains not less than 95.0 percent and not more than 102.0 percent of C25H43NO18, calculated on the anhydrous basis.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
USP Acarbose RS.
USP Acarbose System Suitability Mixture RS.
B: The retention time of the acarbose peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Specific rotation 781S: between +168 and +183.
Test solution: 10 mg per mL, in water.
pH 791: between 5.5 and 7.5, in a solution containing 50 mg per mL.
Water, Method Ic 921: not more than 4.0%.
Residue on ignition 281: not more than 0.2% determined on 1.0 g.
Heavy metals, Method II 231: 0.002%.
Mobile phase, System suitability solution, and Chromatographic system Proceed as directed in the Assay.
Test solution Use the Assay preparation.
Diluted test solution Transfer 1.0 mL of the Test solution to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure Separately inject equal volumes (about 10 µL) of the Test solution and the Diluted test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of each impurity in the portion of Acarbose taken by the formula:
(1/F)(ri / rA)in which F is the relative response factor for each impurity, as listed in Table 1; ri is the individual peak response for each impurity; and rA is the response of the main acarbose peak in the chromatogram obtained from the Diluted test solution. In addition to not exceeding the limits for each impurity in Table 1, not more than 3.0% of total impurities is found.
Phosphate buffer Dissolve 0.6 g of monobasic potassium phosphate and 0.35 g of dibasic sodium phosphate in 900 mL of water, dilute with water to 1 L, and mix.
Mobile phase Prepare a mixture of acetonitrile and Phosphate buffer (750:250). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Reconstitute a vial of USP Acarbose RS in 5.0 mL of water.
System suitability solution Reconstitute a vial of USP Acarbose System Suitability Mixture RS in 1 mL of water.
Assay preparation Transfer about 200 mg of Acarbose, accurately weighed, to a 10-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 210-nm detector and a 4-mm × 25-cm column that contains packing L8. The flow rate is about 2 mL per minute. The column temperature is maintained at 35. Chromatograph the System suitability solution, and identify the acarbose peak and the peaks due to the impurities listed in Table 1. Record the peak responses as directed for Procedure: the ratio of the height of the impurity A peak to the height of the valley between the impurity A peak and the acarbose peak is not less than 1.2. The chromatogram obtained is similar to the chromatogram supplied with USP Acarbose System Suitability Mixture RS.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for all the peaks. Calculate the quantity, in mg, of C25H43NO18 in the portion of Acarbose taken by the formula:
10C(rU / rS)in which C is the concentration, in mg per mL, of USP Acarbose RS in the Standard preparation; and rU and rS are the acarbose peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 1383Pharmacopeial Forum: Volume No. 33(3) Page 388