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

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

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

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<strong>WHO</strong> <strong>Drug</strong> <strong>Information</strong> <strong>Vol</strong>. <strong>24</strong>, <strong>No</strong>. 4, <strong>2010</strong>Consultation DocumentsTime Mobile phase A Mobile phase B Comments(min) (% v/v) (% v/v)0–25 55 to 52 45 to 48 Linear gradient25–40 52 48 Isocratic40–60 30 70 Isocratic60–70 55 45 Isocratic re-equilibrationPrepare the following solutions using water R as diluent. For solution (1) dissolve aquantity of the powder to obtain a solution containing the equivalent of 2.0 mg ofcapreomycin per ml. For solution (2) use an amount of capreomycin sulfate RSequivalent to 2.0 mg of capreomycin per ml.Operate with a flow rate of 1.0 ml per minute. As a detector use an ultraviolet spectrophotometerset at a wavelength of 268 nm.Inject 20 l of solution (1). The assay is not valid unless the resolution between the twomajor peaks corresponding to capreomycin IA and capreomycin IB, with a relativeretention of 0.89 and 1, respectively, is at least 2.0. The assay is also not valid unlessthe resolution between the peaks corresponding to capreomycin IIA and capreomycinIIB, with a relative retention of 0.53 and 0.63, respectively, is at least 3.5.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 capreomycin (sum of the four peakscorresponding to capreomycins IA, IB, IIA and IIB) from the declared content ofcapreomycin in capreomycin sulfate RS.[<strong>No</strong>te from Secretariat: it is proposed that the ICRS will have its content expressed onthe label in terms of capreomycin base and capreomycin sulfate]Efavirenz tabletsDraft proposal for The International Pharmacopoeia (September<strong>2010</strong>). 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 (<strong>No</strong>n-nucleoside Reverse Transcriptase Inhibitor).Storage. Efavirenz tablets should be kept in a well-closed container, protected fromlight.319

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