Determination of impurities of lansoprazole active substance with ultra performance liquid chromatography technique and analytical validation of determination method

Determination of impurities of lansoprazole active substance withultra performance liquid chromatography technique and analyticalvalidation of determination methodIn this study, 7th edition of European Pharmacopoeia wastaken as a reference for the impurities of lansoprazole. Requiredoptimizations were done and an impurity method was developed andvalidated for specified impurities by using UPLC device.A gradient flow system was generated with 0.010M NaH2PO4solution and acetonitrile as a mobile phase. Waters H-CLASS UPLCdevice was used and Acquity UPLC BEH C18 1.7 ?m, 2.1 × 100 mmcolumn was selected as a stationary phase. The wavelength was set at285 nm by the help of software. The column temperature is 25°C,autosampler temperature is 10°C. Injection volume for each solution is 3.0?L. As a solvent, 1 volume of triethylamine and 60 volumes of purifiedwater was mixed and pH was adjusted to 10.5 ± 0.05 with 85% phosphoricacid. Then this solution was mixed with 40 volumes of acetonitrile.The retention times for lansoprazole, impurity A, impurity B,impurity C, impurity D, impurity E, impurity F are 3.655, 2.915, 3.963,4.537, 1.462, 1.582 ve 3.165 minutes respectively.LOQ is 0.000042 mg/mL for impurity A, 0.000064 mg/mL forimpurity B, 0.000066 mg/mL for impurity C, 0.000073 mg/mL for impurityD, 0.000029 mg/mL for impurity E, 0.000043 mg/mL for impurity F.Based on the obtained validation results, a fast, selective,accurate, repeatable and sensitive determination method was generatedfor the impurities of lansoprazole active substance by using UPLC device.Key words: Lansoprazole, impurity, ultra performance liquidchromatography, validation