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Abstract
Pharmaceutical Care and Research: 2018; 18(6):448-451
DOI: 10.5428/pcar20180613
Content determination of bromfenac sodium and related substances in bromfenac sodium eye drops by RP-HPLC method
1. YIN Nan1(1.Department of Pharmacy,Hospital Affiliated to Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China 45181576@qq.com)
2. ZHANG TianYe2(2.Department of Pharmacy,Anorectal Hospital of Shenyang,Liaoning Province,Shenyang 110032,China 121259705@qq.com)
ABSTRACT  Objective: To establish a RP-HPLC method for content determination of bromfenac sodium and related substances in bromfenac sodium eye drops.Methods: Capcellpak C18 column(150 mm×4.6 mm,5 μm) was performed with the mobile phase consisting of 0.05 mol/L ammonium acetate(adjusting pH to 6.0 by glacial acetic acid )-methanol-tetrahydrofuran(68∶22∶10,V/V/V) at a flow rate of 1.0 ml/min.The column temperature was set at 40 ℃ and the determination wavelength was 270 nm.Results: The peaks of the related substances were well separated from the peak of bromfenac sodium,with good specificity.The detection limit of related substances was 1.22×10-5 mg/ml.The concentrations of related substances were in good linearity with the peak area within the ranges of 0.051-10.07 μg/ml(r=0.999 7).The concentration of bromfenac sodium was in good linearity with the peak area within the ranges of 0.012 6-0.302 0 mg/ml (r=0.999 9), with good precision.The recovery rates of low,middle and high concentrations(0.16,0.20,0.24 mg/ml) were (100.7±0.6)%,(100.2±1.1)% and (100.2±0.7)%(n=3),respectively.Conclusion: The established RP-HPLC method could be used for content determination of bromfenac sodium and related substances in bromfenac sodium eye drops.
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Please cite this article as:
YIN Nan1,ZHANG TianYe2,. Content determination of bromfenac sodium and related substances in bromfenac sodium eye drops by RP-HPLC method[J]. Pharmaceutical Care and Research / yao xue fu wu yu yan jiu. 2018; 18(6): 448-451.
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