Resident determination of benzyltrimethylammonium hydroxide in bemiparin sodium by HPLC
An HPLC method for determination of Benzyltrimethylammonium hydroxide was established in Bemiparin sodium.The chromatographic conditions were determined as follows:the analysis is performed on Agilent ZORBAX Eclipse XDB-CN column(250 × 4.6 mm,5 µ m),the column temperature is set to 35 ℃,0.2 mol·L-1 sodium perchlorate solution(Adjusting pH vaule of 2.2 with 1 mol·L-1 perchloric acid)-acetonitrile(88∶12)is adopted as mobile phase,and the flow rate of 0.8 mL·min-1,the detection wavelength of 207 nm,and the sample volume of 50 μ L are adopted.The results show that the concentration of benzyltrimethylammonium hydroxide bears a good linear relationship with peak area within the range of 0.01 to 1.0 μg·mL-1(r=0.999 8,n=7);the RSD of the repeatability test results is 1.21％(n=6);the RSD of the intermediate precision test results is 1.35％(n=12);the RSD of the robustness test results is 1.20％(n=16);the stability of the solution is good within 48 hours with an RSD of 0.19％(n=13);the average recovery rate is 102.40％,with an RSD of 1.70％(n=9).This method is simple to operate,highly sensitive,and provides accurate and reliable results.It can be used for the determination of benzyltrimethylammonium hydroxide residues in Bemiparin sodium.
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