RESUMO
An HPLC method was established for the assay of epinephrine sulfonate (impurity F) in epinephrine injection. The determination was performed on an AQUASIL C18 (100 mm × 4.6 mm, 3 μm) column with a gradient elution system, and the mobile phase was consisted of monopotassium phosphate solution (mobile phase A) and acetonitrile (mobile phase B). The injection volume was 40 μL. The detection wavelength was at 210 nm and the column temperature was 25 ℃. The total analytical time was 40 min. The results showed that the standard cure of epinephrine sulfonate (impurity F) between peak area and concentration exhibited good linear relationship within the ranges of 0.520-12.480 μg·mL-1 and the R2 = 0.999 8. The average recovery rate was 103.04% and the RSD was 2.00%. The limit concentration of detection was 0.104 μg·mL-1 and the limit concentration of quantitation was 0.520 μg·mL-1. The method could be applied to the determination of epinephrine sulfonate in epinephrine injection with high accuracy and precision, as well as good sensitivity. It could also enhance the quality standards of epinephrine-related products.
RESUMO
Objective To establish a method for the chiral separation and determination of S-isomer in epinephrine hydrochloride injection by HPLC with chiral mobile phase additives. Methods Column of Purospher? STAR RP-18 (4. 6 mm×250 mm, 5 μm) was used. The mobile phase was acetonitrile-10 mmol·L-1 sodium dihydrogen phosphate buffer containing 10 mmol·L-1 sulfobutylether-b-cyclodextrin (pH adjusted to 3. 0 with phosphoric acid) (98. 5:1. 5), detection wavelength was 280 nm, the flow rate was 0. 8 mL·min-1 , and the column temperature was 30 ℃ . Results Good linear relationship was established between the peak area and the concentration of S-isomer over the range of 5. 02-1501. 50 μg·mL-1 (R2 =0. 999 7). The detection limit was 0. 05 μg·mL-1 . Conclusion The proposed method shows high repeatability and durability. It can be employed for the quality control of S-isomer in epinephrine hydrochloride injection.
RESUMO
BACKGROUND/AIMS: Many studies have been performed to find the differences between using epinephrine injection alone and a combination therapy with hemoclip for bleeding peptic ulcer, but the results have been controversial. We retrospectively evaluated the hemostatic efficacy for epinephrine injection alone and injection combined with hemoclip for bleeding peptic ulcers. METHODS: Four hundred patients were enrolled. They were assigned to one of the two groups: endoscopic hemostasis with injection of epinephrine (group I, n=156) and combined epinephrine injection with hemoclip (group II, n=244). RESULTS: The continuous bleeding rate was significantly higher in group I than in group II. The recurrent bleeding rate was also significantly higher in group I than in group II. There were no statistical differences in the rates of death, emergency surgery and arterial embolization. The rates of continuous bleeding and the initial failure of hemostasis were higher for the patients with active bleeding on the initial endoscopy irrespective of the applied hemostatic methods. CONCLUSIONS: A combination of epinephrine injection and hemoclip is more effective than epinephrine injection alone for treating bleeding peptic ulcers.