Determination of Loratadine Related Substances and Content by HPLC
Objective:HPLC method for the determination of related substances and contents of loratadine was established.Methods:The chromatographic column was Waters symmetry C 8(4.6 mm×150 mm,5 μm),the mobile phase was 0.01 mol/L dipotassium phosphate solution-methanol-acetonitrile(36:32:32)(pH adjusted to 7.2±0.05 with phosphoric acid),the column temperature was 30℃ and the flow rate was 1.0 mL/min.The detection wavelength was 254 nm,the injection volume of related substances was 50 μl and the injection volume of content was 15 μL.Results:The separation of each chromatographic peak was good,and the applicability of the system met the requirements.Blank solvent,forced degradation test without interference;The content of loratadine in the concentration range of 0.2028 mg/mL～0.6084 mg/mL was linearly correlated with peak area(r=0.9999),and the related substance impurity D in the range of 0.1874 μg/mL～0.5621 μg/mL,impurity G in the range of 0.2092 μg/mL～0.6276 μg/mL,impurity F in the range of 0.4214 μg/mL～1.2641 μg/mL,and loratadine in the range of 0.3826 μg/mL～1.1477 μg/mL were linearly correlated with the peak area,the correlation coefficients r were 0.9996,0.9998,0.9997 and 0.9996,respectively.The test results of precision,repeatability,recovery and durability were good.Stable within 48 hours.Conclusion:The method is simple,accurate and stable,and can be used to determine the content of loratadine and related substances.
万方数据
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