Analysis of Sorbitol in Nicardipine Hydrochloride Injection (NH2P-50 4E)

Nicardipine hydrochloride injection is used for hypertensive emergencies and acute heart failure. According to the United States Pharmacopeia and the National Formulary (USP-NF 2022 Issue 2*), analysis of sorbitol content in nicardipine hydrochloride injection should be carried out with a column filled with L8 packing material (aminopropylsilane chemically bonded to totally porous silica gel). Meanwhile, this application shows that a polymer-based amino column, Asahipak NH2P-50 4E is also feasible analyzing sorbitol content in nicardipine hydrochloride injection following the similar conditions mentioned in the monogram.

(Note)
Asahipak NH2P-50 4E is a L82 column.

*The version at the time of the application acquisition.

Sample: 25 µL

  1. 1.Sorbitol 4.8 mg/mL
Chromatogram of Sorbitol
Column
Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent
CH3CN and 1 g/L of Tetrabutylammonium hydrogen sulfate in water (70:30)
Flow rate
1.0 mL/min
Detector
RI (50 ℃)
Column temp.
40 ℃

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