To establish a LC-MS/MS method for the determination of the residual quantity of potential genetoxic impurity 9-nitrominocycline in tigecycline.The chromatog. conditions were as follows: a Welch ZORBAX XB-C₁₈ (4.6×50 mm, 5 μm) column using acetonitrile-water (containing 0.1% formic acid) as the mobile phase in gradient elution.The flow rate was 0.5 mL·min^-1.The mass spectrometry conditions were as follows: electrospray ionization source (ESI), multistage reaction monitoring (MRM), pos. ion scanning mode, ion spray voltage of 3500 V, ion source temperature of 300°C, Sheath Gas Temp of 350°C, Sheath Gas Flow of 11 L/min, ion collision energy of 34 V and scan time of 500 ms.The MRM ion pair for quant. anal. was m/z→503.2/153.9.The linear range of 9-nitrominocycline was 0.0125∼0.9580 μg·mL^-1 (r=0.9999).The limit of detection was 0.0067 μg·mL^-1 and the limit of quantitation was 0.0125 μg·mL^-1.The average recovery was 94.4%∼100.8%.The method is simple, rapid and accurate, and can be used for the quality control of 9-nitrominocycline in tigecycline.

Shandong Huagong

Evaluation of the crystallization tendency of amorphous tacrolimus by discriminative dissolution method

Author: Xia, Li ; Dong, Fuxia ; Yi, Fenfen

Compare the dissolution behavior of solid dispersion (SD) of tacrolimus in different media and different media volumes, and establish a discriminative dissolution profile.Pure amorphous tacrolimus and tacrolimus SD with 0∼100% Crystallinity were prepared as the investigation samples, and the dissolution profile of each sample under four media of pH value 1.2, 4.5, 6.8 and water containing 0.005% HPC was investigated, and finally confirmed that the dissolution conditions of tacrolimus SD: pH value 4.5 (containing 0.005% HPC) dissolution medium volume 500 mL, 37°C, stirring at speed 50r/min, sampling at 0.5, 1, 1.5, 2, 2.5, 3, 4 h points resp.The dissolution curve method established in this study can distinguish the subtle crystal transformation behavior, and can be used to guide the optimization and quality control of SD preparation process.

Zhongguo Xiandai Yingyong Yaoxue

Determination of Rivaroxaban in Beagle Dog Plasma by UHPLC-MS/MS with Deuterium Substituted Rivaroxaban as Internal Standard and Its Application in Pharmacokinetics Studies

Author: Du Jiaqiu ; Cai Qiuhua ; Dong Fuxia

OBJECTIVE To establish an UPLC-MS/MS method for the determination of rivaroxaban in Beagle dog plasma.METHODS The plasma samples were treated with protein precipitated by Me tert-Bu ether-dichloromethane(2:1), the deuterium substituted rivaroxaban(rivaroxaban-d4) was selected as internal standardThe chromatog. separation was performed with a Thermo BDS Hypersil C_(18)column(100 mmx4.6 mm, 2.4 μm) and gradient mobile phase(mobile phase A was methanol solution containing 0.015 mol·L∼(-1) ammonium formate and 0.1% formic acid; mobile phase B was water-methanol(90:10) solution containing 0.015 mol·L∼(-1) ammonium formate and 0.1% formic acid.).Mass spectrometry conditions were ESI+ with multiple reaction monitoring(MRM) mode.The ion reactions used for quant. detection were [M+H]∼+ m/z 436@30 eV→ m/z 144.900(rivaroxaban) and [M+H]∼+ m/z 440@24 eV→m/z 144.900(rivaroxaban-d4).RESULTS Good linearity was obtained for rivaroxaban in the range of 0.5-400 ng·mL∼(-1)(r=0.996 1), the lower quantification of current method was 0.5 ng·mL∼(-1) for rivaroxaban.The intra-and inter-batch precision were <13%.The absolute recoveries ranged from 89.4% to 96.5% and the matrix effects were 94.7%-97.2%.The plasma samples were stored frozen(-80 °C) for 33 d with good stability.After three freeze-thaw cycles of the samples and at room temperature for 12 h after extraction, the change in samples concentration were not obvious.It was applied in dog pharmacokinetic study after oral administration of rivaroxaban tablets.The main pharmacokinetic parameters were as follows: T_(max)(2.11±1.133)h, C_(max)(179.3±50.65)ng·mL∼(-1), t_(1/2)(10.05±4.34)h, AUC_(0-t)(1161.6±339.74)h·ng·mL∼(-1).CONCLUSION The trial results show that the method is simple in operation, high in sensitivity, good in reproducibility, accurate and reliable, and can be used to determine the concentration of rivaroxaban in Beagle dog plasma and in vivo pharmacokinetic studies in Beagle dog.

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