Dinoprost Tromethamine
C20H34O5·C4H11NO3
475.62
Prosta-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9,11,13E,15S)-, compd. with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). (E,Z)-(1R,2R,3R,5S)-7-[3,5-Dihydroxy-2-[(3S)-(3-hydroxy-1-octenyl)]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Prostaglandin F2a tromethamine [38562-01-5]. » Dinoprost Tromethamine contains not less than 95.0 percent and not more than 105.0 percent of C20H34O5·C4H11NO3, calculated on the dried basis. [CautionGreat care should be taken to prevent inhaling particles of Dinoprost Tromethamine and exposing the skin to it.
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Packaging and storage
Preserve in tight containers.
Specific rotation 781S:
between +19 and +26.
Test solution:
20 mg per mL, in alcohol.
Loss on drying 731
Dry it in vacuum at room temperature and at a pressure not exceeding 5 mm of mercury for 16 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281:
not more than 0.5%.
Chromatographic purity
[notePrepare solutions immediately prior to use.]
Mobile phase
Proceed as directed in the Assay.
Standard stock solution
Prepare as directed for Standard preparation in the Assay.
Standard solution
Transfer 1.0 mL of the Standard stock solution to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Test solution
Prepare as directed for the Assay preparation.
Chromatographic system
Proceed as directed in the Assay. Chromatograph the Test solution, and record the peak responses as directed for Procedure: the resolution, R, between dinoprost tromethamine and any other adjacent peak is not less than 1.0.
Procedure
Separately inject equal volumes (about 10 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of each impurity in the portion of Dinoprost Tromethamine taken by the formula:
2.5(C/W)F(ri / rS)
in which C is the concentration, in µg per mL, of USP Dinoprost Tromethamine RS in the Standard solution; W is the weight, in mg, of Dinoprost Tromethamine taken to prepare the Test solution; F is the relative response factor and is equal to 0.25 for any peak at a relative retention time of about 0.30, 1.7 for any peak at a relative retention time of about 1.15, and 1.0 for any other peak; ri is the peak response of each impurity obtained from the Test solution; and rS is the peak response of dinoprost tromethamine obtained from the Standard solution: not more than 2.0% of any impurity having a relative retention time of about 0.94 is found; not more than 1.5% of any impurity having a relative retention time of about 0.84 is found; not more than 0.5% of any other impurity is found; and not more than 2.0% of all other impurities is found.
Assay
[notePrepare solutions immediately prior to use.]
Mobile phase
Prepare a filtered and degassed mixture of water, acetonitrile, and phosphoric acid (750:250:1). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation
Dissolve an accurately weighed quantity of USP Dinoprost Tromethamine RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1.0 mg per mL.
Assay preparation
Transfer about 25.0 mg of Dinoprost Tromethamine, accurately weighed, to a 25-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)
The liquid chromatograph is equipped with a 200-nm detector and a 3.9-mm × 15-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 6000 theoretical plates, and the relative standard deviation for replicate injections is not more than 2.0%.
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 C20H34O5·C4H11NO3 in the portion of Dinoprost Tromethamine taken by the formula:
25C(rU / rS)
in which C is the concentration, in mg per mL, of USP Dinoprost Tromethamine RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 2171
Pharmacopeial Forum: Volume No. 28(4) Page 1102
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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