The suspension was again removed from the mortar using the same 50-mL oral enteral syringe, which was connected to the NG tube at the Luer-lock connection, and the contents were passed through the NG tube and collected for
HPLC analysis. Finally, using the same 50-mL PVC oral enteral syringe, 25 mL of purified water was flushed through the NG tube. Each of the collected flushes was analyzed separately by HPLC. Fig. 2 Schematic diagram of NG tube administration. NG naso-gastric, HPLC high performance liquid chromatography, PVC polyvinylchloride 2.3 Sample Analysis In order to determine the recoverability of ticagrelor, the flushes for each method were prepared for HPLC analysis and collected in volumetric flasks. The collected oral doses and flushes were each diluted up to 200 mL with 70/30 (volume/volume [v/v]) acetonitrile/water; the check details collected NG tube doses and flushes were each www.selleckchem.com/products/bmn-673.html diluted up to 100 mL with 70/30 (v/v) acetonitrile/water. A 10-mL aliquot of the 180-mg samples was diluted up to 20 mL with 35/65 (v/v) acetonitrile/water. The concentration of ticagrelor was determined by comparing the values from HPLC analysis of the ticagrelor sample with values from a ticagrelor reference standard solution prepared at a similar nominal concentration and analyzed in the same way. The ticagrelor sample and reference standard solutions were analyzed by isocratic reversed phase
HPLC and ultraviolet detection using appropriate column and chromatographic conditions. The amount of drug recovered was expressed as a percentage of the total intact ticagrelor dose (either 90 or 180 mg [label claim]). Experiments for each method were repeated three times. The results were expressed as the mean percentage of recovery of the intact dose. Release testing, including measurement PAK5 of ticagrelor tablet content uniformity, was performed using standardized methods. The in-use stability of the aqueous suspensions of ticagrelor tablets (90- and 180-mg doses) held within the 50-mL PVC oral enteral syringe for up to 2 h (i.e., 0, 1, and 2 h) was examined. HPLC analysis measured the degradation products. 3 Study Endpoints The primary endpoint of the study was the mean percentage of
ticagrelor recovered from the samples compared with the intact tablet dose for each method of administration, for both the 90- and 180-mg ticagrelor doses. Recovery was considered acceptable if the EPZ015938 mouse average recovery exceeded 95 %. The in-use stability of aqueous suspensions of ticagrelor tablets, in terms of the observed level of degradation, was also quantified. 4 Results Data for the mean percentage recovery of ticagrelor are shown in Table 1. Table 1 Mean percentage recovery of ticagrelor following oral and NG tube administration Administration method 90-mg dose 180-mg dose Mean % recovery [range]a Mean % recovery [range]a Crushed oral dose 99.47 [98.43–100.08] 99.20 [98.19–100.05] NG tube PVC 99.12 [97.86–100.68] 97.25 [96.45–97.98] PUR 100.43 [95.28–103.89] 97.92 [97.26–98.
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