RP_HPLC测定溴芬酸钠滴眼液中苯扎溴铵的含量.pdfVIP

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RP_HPLC测定溴芬酸钠滴眼液中苯扎溴铵的含量.pdf

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RP_HPLC测定溴芬酸钠滴眼液中苯扎溴铵的含量

Food and Drug 2015 17 2 111 RP-HPLC 1. 250101 2. 250101 RP-HPLC Zorbax C18 250 mm4.6 mm5 μm0.003 mol/L1000 mL10 mLpH 3.0) - 40:601.0 mL/min214 nm20 μL 10.10~202.00 μg/mLr=0.9999 24 h62 ng R917 A 1672-979X2015 02-0111-03 Determination of Benzalkonium Bromide in Bromfenac Sodium Eye Drops by RP-HPLC 1 2 2 1 YANG Hai-xia , XING Yu-ren , DONG Ai-mei , WANG Shu-hua (1. Shandong Provincial Key Laboratory of Biopharmaceuticals, Shandong Academy of Pharmaceutical Sciences, Jinan 250101, China; 2. Shandong Provincial Key Laboratory of Mucosal and Transdermal Drug Delivery Technologies, Shandong Freda Pharmaceutical Group Co. Ltd., Jinan 250101, China) Abstract: Objective To establish a RP-HPLC method for the determination of benzalkonium bromide in Bromfenac Sodium Eye Drops. Methods The chromatographic column was Zorbax C18 (250 mm4.6 mm, 5 μm). The mobile phase was 0.003 mol/L ammonium phosphate dibasic solution (consisting of 10 mL triethylamine per 1000 mL, adjusted to pH 3.0 by phosphoric acid)-acetonitrile (40:60). The ﬂ ow rate was 1.0 mL/min. The detection wavelength μ Results was 214 nm. The injection volume was 20 L. The solution absent of benzalkonium bromide had no interference to the determination. The calibration curve was linear in the concentration range of 10.10-202.00 μg/mL (r=0.9999) for benzalkonium bromide. The precision, reproducibility, recovery and durability were good. The sample solution was stable in 24 h. The quantitation limit of benzalkonium bromide was 62 ng. Concl