Sumatriptan Succinate Oral Suspension
» Sumatriptan Succinate Oral Suspension is a suspension of Sumatriptan Succinate. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of sumatriptan (C14H21N3O2S). Prepare Sumatriptan Succinate Oral Suspension 7 mg per mL of Sumatriptan Succinate equivalent to 5 mg of Sumatriptan per mL as follows (see Pharmaceutical CompoundingNonsterile Preparations 795):
If using Tablets, place the Sumatriptan Tablets in a suitable mortar, and comminute to a fine powder, or add Sumatriptan Succinate powder to the mortar. Add about 25 mL of Vehicle in portions, mixing thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add sufficient Vehicle to bring to final volume, and mix well.
Packaging and storage Preserve in tight, light-resistant containers. Store in a cold place.
Labeling Label it to state that it is to be well shaken before use, and to state the beyond-use date. Label content as: Each mL of Sumatriptan Succinate Oral Suspension contains 7 mg of Sumatriptan Succinate equivalent to 5 mg of Sumatriptan.
pH 791: between 3.6 and 4.6.
Beyond-use date: 14 days after the day on which it was compounded.
Mobile phase Prepare a solution of 0.01 M dibutylamine in 0.025 M aqueous monobasic sodium phosphate dihydrate and acetonitrile (75:25). Adjust Mobile phase with 1 N sodium hydroxide to a pH of 8.0, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Internal standard solution Dissolve an accurately weighed quantity of N-hydroxymethylsumatriptan succinate in Mobile phase to obtain a known concentration of about 3.0 mg per mL.
Standard stock preparation Dissolve an accurately weighed quantity of USP Sumatriptan Succinate RS in Mobile phase to obtain a known concentration of about 4.0 mg per mL.
Standard preparation Dilute the Standard stock preparation with Mobile phase to obtain a solution having a known concentration of about 120 µg per mL. Each solution contains 30 µg per mL of Internal standard solution.
Assay preparation Transfer about 1 mL of Oral Suspension from each bottle to a suitable container, and dilute with 0.1 M hydrochloric acid to obtain a concentration of about 0.15 mg per mL. Pass the solution through a 0.22-µm syringe filter into a 0.3-mL polypropylene sample vial for assay.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 282-nm detector and a 4.6-mm ×10-cm analytical column that contains 5-µm packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the retention times for sumatriptan and N-hydroxymethylsumatriptan are 11 and 14 minutes, respectively; and the relative standard deviation for replicate injections is not more than 1.5%.
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 the major peaks. Calculate the quantity, in mg, of sumatriptan succinate (C14H21N3O2S·C4H6O4) in the volume of Oral Suspension taken by the formula:
100(C/V)(rU / rS)in which C is the concentration, in mg per mL, of USP Sumatriptan Succinate 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 3643Pharmacopeial Forum: Volume No. 32(1) Page 144