生物分析および生物医学ジャーナル

Cytomegalovirus belongs to the family herpesviridae, it is important cause of abortion, mental retardation and fetal death. This study was conducted to determine the occurrence of IgM and IgG antibodies in sera and CMV antigens in saliva in women with recurrent abortion and the effect of the virus on some haematological criteria in those women. It is concluded that IgG titre is higher in women who were between 36-40 years of age than other ages. After 40 years fetal death increased especially in women with positive IgG. Furthermore, the virus affect haematological criteria causing anemia and leucopenia.

The objective of present research work is to develop a suitable LCMS/MS method for the quantitative determination of genotoxic impurity 4-Chloro-1-Hydroxy Butane Sulfonic Acid Sodium Salt at ppm level present in Sumariptan dug substance. The LCMS/MS method was developed on Zorbax SB-C8 column using the mobile phase consists a mixture of 0.05% (v/v) Formic acid in water and Acetonirile using a isocratic composition of 90:10 (v/v) at a flow rate of 0.8 mL/min. Ion source is electospray ionization (ESI), source temperature is 325°C, gas flow is 8 L/min, Nebuliser pressure is 40 psi, capillary voltage is 4000 V. Under these conditions impurity was quantified by selecting most stable MRM pair (187/81). The limit of detection and the limit of quantitation for the impurity were established. Validation of the developed LCMS/MS method was carried out as per ICH requirements and the data shows that the proposed method is specific, linear, accurate, precise and robust. This method has been tested in a number of Sumatriptan samples and used successfully for quantification of the impurity at ppm level. The developed LCMS/MS method was found to be suitable to quantify the genotoxic impurity 4-Chloro-1-Hydroxy Butane Sulfonic Acid Sodium Salt at ppm level present in Sumatriptan Succinate.