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Asimple, selective validatedmethod for simultaneous estimation of zuclomifene and enclomifene in human plasma by liquid chromatography - tandemmass spectrometry

Arvind G.Jangid, Rajesh H.Tale, Vikas V.Vaidya

Asimple and selectivemethod for estimation of zuclomifene and enclomifene in human plasma was developed and validated using glipizide as internal standard. The analytes were chromatographed onACQUITY UPLC® BEH C18 1.7µ (2.1 mm x 100 mm) reverse phase column under isocratic conditions using 5mMAmmoniumAcetate inwater (pH4.00 ± 0.05): methanol (38:62 v/ v) as the mobile phase and detected by tandem mass spectrometry in positive ion mode. The ion transition recorded in multiple reaction monitoring mode were m/z 406.2 100.0 for zuclomifene and enclomifene and m/z 446.1321.0 for internal standard. Simple solid phase extraction method used for extraction of analytes and internal standard from plasma. Linearity in plasma was observed over the concentration range 0.102 – 15.225 ng/mL for zuclomifene and 0.149 – 22.275 ng/mL for enclomifene. The method was validated for sensitivity, matrix effect, accuracy and precision, linearity, recovery and stability studies. The lower limit of quantification of zuclomifene and enclomifene was 0.102 ng/mL and 0.149 ng/mLrespectively. The mean recovery for zuclomifene and enclomifene was 88.2 % and 85.7 % respectively. The coefficient of variation of the assaywas less than 11.7%and 12.3 %and accuracyof 91.3%to 105.7%and 91.2%to 106.6%for zuclomifene and enclomifene respectively. The validated method can be applied to pharmacokinetic study of clomifene.