Dipyridamole Oral Suspension
» Dipyridamole Oral Suspension contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of dipyridamole (C24H40N8O4). Prepare Dipyridamole Oral Suspension 10 mg per mL as follows (see Pharmaceutical CompoundingNonsterile Preparations 795):
If using Tablets, place the Dipyridamole Tablets in a suitable mortar, and comminute to a fine powder, or add Dipyridamole powder to the mortar. Add about 20 mL of Vehicle, and mix to a uniform paste. Add the Vehicle in small portions, and mix well after each addition. Transfer, stepwise and quantitatively, to a graduated or calibrated bottle. Add the Vehicle in portions to rinse the mortar, add sufficient Vehicle to bring to final volume, and mix well.
Packaging and storage Preserve in tight, light-resistant containers. Store at controlled room temperature, or in a cold place.
Labeling Label it to state that it is to be well shaken, and to state the beyond-use date.
pH 791: between 3.8 and 4.8.
Beyond-use date: 60 days after the day on which it was compounded.
Mobile phase Dissolve 250 mg of dibasic sodium phosphate in 250 mL of water, and adjust with dilute phosphoric acid (1 in 3) to a pH of 4.6. Add 750 mL of methanol, mix, pass through a 0.5-µm membrane filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Dissolve USP Dipyridamole RS in Mobile phase to obtain a suspension having a known concentration of 100 µg per mL.
Assay preparation Agitate the container of Oral Suspension for 30 minutes on a rotating mixer, remove a 5-mL sample, and store in a clear glass vial at 70 until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix with a vortex mixer for 30 seconds. Pipet 1.0 mL of the sample into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 288-nm detector and a 4.6-mm × 25-cm analytical column that contains 5-µm packing L1. The flow rate is about 1.3 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the retention time is about 7.3 minutes, and the relative standard deviation for replicate injections is not more than 2.3%.
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of dipyridamole ( C24H40N8O4) in the volume of Oral Suspension taken by the formula:
100(C / V)(rU / rS)in which C is the concentration, in µg per mL, of USP Dipyridamole RS in the Standard preparation; V is the volume, in mL, of Oral Suspension taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 2182Pharmacopeial Forum: Volume No. 32(1) Page 81