Determination of meglumine in lansoprazole for injection by HPLC-NQAD

doi:10.19803/j.1672-8629.20230045

Abstract

Abstract: Objective To establish a method for determining the content of meglumine in lansoprazole for injection based on HPLC-NQAD. Methods The HPLC-NQAD method was established on a CAPCELL PAK CR 1:4 column(2.0 mm × 150 mm, 5 μm) by using a mobile phase of 5 mmol·L-1 ammonium formate-2% acetonitrile(A) and 50 mmol·L-1 ammonium formate-50% acetonitrile(B) under gradient elution at a flow rate of 0.3 mL·min-1. The column temperature was 40℃, injection volume was 5 μL, NQAD evaporation temperature was 35℃, atomization temperature was 30℃, and nitrogen pressure was 30 psi. Results Meglumine was separated completely in the test solution. The calibration curve was linear within the range of 1.0 µg·mL-1 to 100.0 µg·mL-1 for meglumine(r = 0.999 8). The average recovery was 99.96%, and the RSD was 1.01%. Conclusion This method has proved to be simple, accurate, sensitive and reliable. It can be used for the determination of meglumine in lansoprazole for injection.

Key words: HPLC-NQAD, lansoprazole, injection, meglumine, cosolvent, determination

CLC Number:

R917

YANG Qian, HUI Yanchun, WANG Chen, ZHANG Xianhua, XU Mingzhe. Determination of meglumine in lansoprazole for injection by HPLC-NQAD[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 361-364.

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