Abstract
A validated bioanalytical method has been developed for the determination of a new anxiolytic compound of deramciclane in dog plasma, using Lichrolut RP-18 solid-phase extraction and gas chromatography with nitrogen-phosphorous selective detector (GC-NPD). Gas-chromatographic separation was carried out by SPB-5 fused silica capillary column (30 m x 0.25 mm x 0.25 μm) after split injection, when the split liner was packed (3% silicone SE 30). An optimized two-level oven temperature program was used for the separation. The assay was validated with respect to selectivity, specificity, linearity, sensitivity, accuracy, precision, system suitability and plasma stability. All validation parameters were found to be within the internationally required limits. The limit of quantification of deramciclane in dog plasma was found to be 0.5 ng mL-1. The calibration curve showed good linearity (r = 0.999) over the 0.5 and 100 ng mL-1 deramciclane plasma concentration range. The assay is sufficiently sensitive and relatively fast (12.5 min chromatographic run) to be used for routine monitoring and pharmacokinetic studies of deramciclane.
| Original language | English |
|---|---|
| Pages (from-to) | 497-501 |
| Number of pages | 5 |
| Journal | Pharmaceutical Sciences |
| Volume | 3 |
| Issue number | 10 |
| Publication status | Published - 1997 |
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A sensitive, validated gas-chromatographic bioanalytical method by nitrogen selective detection of deramciclane in dog plasma. / Klebovich, I.; Leibinger, J.; Abermann, M.; Grezal, G.
In: Pharmaceutical Sciences, Vol. 3, No. 10, 1997, p. 497-501.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A sensitive, validated gas-chromatographic bioanalytical method by nitrogen selective detection of deramciclane in dog plasma
AU - Klebovich, I.
AU - Leibinger, J.
AU - Abermann, M.
AU - Grezal, G.
PY - 1997
Y1 - 1997
N2 - A validated bioanalytical method has been developed for the determination of a new anxiolytic compound of deramciclane in dog plasma, using Lichrolut RP-18 solid-phase extraction and gas chromatography with nitrogen-phosphorous selective detector (GC-NPD). Gas-chromatographic separation was carried out by SPB-5 fused silica capillary column (30 m x 0.25 mm x 0.25 μm) after split injection, when the split liner was packed (3% silicone SE 30). An optimized two-level oven temperature program was used for the separation. The assay was validated with respect to selectivity, specificity, linearity, sensitivity, accuracy, precision, system suitability and plasma stability. All validation parameters were found to be within the internationally required limits. The limit of quantification of deramciclane in dog plasma was found to be 0.5 ng mL-1. The calibration curve showed good linearity (r = 0.999) over the 0.5 and 100 ng mL-1 deramciclane plasma concentration range. The assay is sufficiently sensitive and relatively fast (12.5 min chromatographic run) to be used for routine monitoring and pharmacokinetic studies of deramciclane.
AB - A validated bioanalytical method has been developed for the determination of a new anxiolytic compound of deramciclane in dog plasma, using Lichrolut RP-18 solid-phase extraction and gas chromatography with nitrogen-phosphorous selective detector (GC-NPD). Gas-chromatographic separation was carried out by SPB-5 fused silica capillary column (30 m x 0.25 mm x 0.25 μm) after split injection, when the split liner was packed (3% silicone SE 30). An optimized two-level oven temperature program was used for the separation. The assay was validated with respect to selectivity, specificity, linearity, sensitivity, accuracy, precision, system suitability and plasma stability. All validation parameters were found to be within the internationally required limits. The limit of quantification of deramciclane in dog plasma was found to be 0.5 ng mL-1. The calibration curve showed good linearity (r = 0.999) over the 0.5 and 100 ng mL-1 deramciclane plasma concentration range. The assay is sufficiently sensitive and relatively fast (12.5 min chromatographic run) to be used for routine monitoring and pharmacokinetic studies of deramciclane.
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M3 - Article
VL - 3
SP - 497
EP - 501
JO - Journal of Pharmacy and Pharmacology
JF - Journal of Pharmacy and Pharmacology
SN - 0022-3573
IS - 10
ER -