WHO Drug Information Vol. 24, No. 4, 2010

Consultation DocumentsWHO Drug Information Vol. 24, No. 4, 2010Prepare the following solutions using a mixture of 20 volumes of acetonitrile R and 80volumes of water R as a diluent. For solution (1): weigh and mix the contents of 20capsules and disperse a quantity containing about 50 mg of Emtricitabine in 80 ml ofthe diluent, dilute to 100 ml with the diluent, filter and use the filtrate.For solution (2) use 0.5 mg of emtricitabine RS per ml of the diluent.For the system suitability test: prepare solution (3) using 5 ml of solution (1) and 2 mlof phosphoric acid (~105 g/l) TS, heat carefully in a boiling water-bath for 15 minutes.Inject 20 l of solution (3). The test is not valid unless the resolution between the peakdue to emtricitabine (retention time about 9 minutes) and the peak with a relativeretention of about 1.3 is not less than 6.Inject separately 20 µl each of solutions (1) and (2).Measure the areas of the peak responses obtained in the chromatograms from solutions(1) and (2), and calculate the content of emtricitabine (C 8H 10FN 3O 3S).B. Weigh and mix the contents of 20 capsules and disperse a quantity containingabout 50 mg of Emtricitabine in 40 ml of methanol R, dilute to 50 ml with methanol Rand filter. Dilute 1 ml of the filtrate to 50 ml with methanol R.Measure the absorbance (1.6) of the resulting solution in a 1-cm layer at the maximumat about 284 nm.Calculate the content of emtricitabine (C 8H 10FN 3O 3S) ,using the absorptivity value of33.2 (A 1% 1cm= 332).* * *New reagent to be added to The International Pharmacopoeia:Hydrochloric acid (~4 g/l) TS.Dilute 10 ml of hydrochloric acid (~420 g/l) TS with sufficient water to produce 1000 ml(approximately 0.1 mol/l).Emtricitabini et tenofoviri compressiEmtricitabine and tenofovir tabletsDraft proposal for The International Pharmacopoeia (September2010). Please address any comments to Quality Assurance andSafety: Medicines, World Health Organization, 1211 Geneva 27,Switzerland. Fax +41227914730 or e-mail to mendyc@who.int. Asubscriber mailing list is now available to speed up consultation.For more information please contact bonnyw@who.int.Category. Antiretroviral (Nucleoside/Nucleotide Reverse Transcriptase Inhibitor).330