Abstract：
:An HPLC-MS/MS method was developed and validated for the determination of dihydralazine in human plasma. HPLC-MS/MS has not been used before in a published paper and provides better sensitivity and selectivity. Therefore a much easier sample preparation than published before is feasible (protein precipitation). As this substance is rather reactive and sensitive some specific care has to be taken hindering the conversion of the substance in whole blood and following human plasma after blood withdrawal. Hydrazines often are used for derivatization of aldehydes and ketones. With specific care (using 1,4-dithiothreitol (DTT) and cooling) dihydralazine can be preserved and analysed without decomposition or conversion in the tested range of 0.500-302 ng/mL of human plasma. The following inter-batch precision and accuracy of the Quality Control Samples resulted: QC-A (1.34 ng/mL plasma) with a precision of coefficient of variation (CV) 7.66% and an accuracy of 103.2%; QC-B (18.2 ng/mL 7.86%, acc. 101.3%); QC-C (258 ng/mL, 9.73%, acc. 98.3%). The inter-batch values of the LLOQ samples at 0.500 ng/mL were 7.17% for CV and accuracy of 106.4%. Mean recovery tested at the QC levels was found to be 103.8%. Specificity in six different plasma samples was good (<10% of the area of the LLOQ). Stability in plasma was tested under different conditions and was sufficient.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Mascher DG,Tscherwenka W,Mascher HJdoi
10.1016/j.jpba.2006.07.041subject
Has Abstractpub_date
2007-01-17 00:00:00pages
631-45issue
2eissn
0731-7085issn
1873-264Xpii
S0731-7085(06)00489-4journal_volume
43pub_type
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