Research Article

Simultaneous Determination of 15 Sulfonate Ester Impurities in Phentolamine Mesylate, Amlodipine Besylate, and Tosufloxacin Tosylate by LC-APCI-MS/MS

Table 1

Drug products tested.

ProductManufactureBatch numberStrengthRecommended upper limit daily dosageLimit of PGIs based on 1.5 μg/day

Amlodipine besylate tabletPfizer Inc. (NY, NY, USA)201705205 mg10 mg150 μg/g
Phentolamine mesylate tabletBeijing Shuguang Pharmaceutical Industrial Co., Ltd. (Beijing, China)17021540 mg60 mg25 μg/g
Tosufloxacin tosylate tabletChifeng Wanze Pharmaceutical Co., Ltd. (Chifeng, Neimenggu, China)1705240.15 g0.6 g2.5 μg/g