Determination of Lansoprazole and Its Related Substance in Lansoprazole for Injection by HPLC
Abstract
OBJECTIVE To establish a HPLC method for determing the content of lansoprazole and screening its related substance in lansoprazole for injection.METHODS A Diamonsil-C_(18) column(4.6 mm×200 mm,5 μm) was used.The mobile phase was methanol-water-triethylamine-phosphoric acid(640∶360∶5∶1.5,pH 7.3).The determination wavelength was 284 nm.RESULTS The excipients did not interfere with the determination of lansoprazole.Lansoprazole and its related substance were absolutely separated.The linear range of lansoprazole was 10.0～400.0 mg·L~(-1).The precision of the method(RSD=0.13%)was good.The average recovery was 99.6%.CONCLUSION The method is simple,speedy,accurate and specific.
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