Determination of 7 N-nitrosoamines in Metformin Hydrochloride Sustained Release Tablets by LC-HRMS

doi:10.19803/j.1672-8629.2021.05.11

Abstract

Abstract: Objective To establish an LC-HRMS method for determination of 7 N-nitrosoamines(7 NAs) genotoxic impurities in metformin hydrochloride sustained release tablets. Methods The separation was carried out on a C18 column (100 mm×4.6 mm, 3μm) by linear gradient elution using 0.1% formic acid as mobile phase A and 0.1% formic acid methanol as mobile phase B. The HRMS determination of NDMA was conducted by means of positive electrospray ionization parallel reactions monitoring. Results Linear calibrations were established for 7NAs in the range of 1 to 100 ng/mL. The limits of quantification ranged from 0.5 to 1 ng/mL while the average recovery ranged from 82.6% to 111.4%. Conclusion The established LC-HRMS method has proved to be suitable for the simultaneous quantitative determination of 7 NAs genotoxic impurities in metformin hydrochloride sustained release tablets.

Key words: metformin hydrochloride sustained release tablets, N-nitrosamine, HRMS, genotoxic impurities, quantitative analysis, sensitivity

CLC Number:

R917

LIU Bo, ZHANG Tong, HUANG Lu, ZHANG Qingsheng, FAN Huihong. Determination of 7 N-nitrosoamines in Metformin Hydrochloride Sustained Release Tablets by LC-HRMS[J]. Chinese Journal of Pharmacovigilance, 2021, 18(5): 454-458.

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