Determination of three principal components and meglumine in TALICA sustained release capsules by HPLC
Objective To set up the content of three principal components of amoxicillin,omeprazole magnesium,rifabutin and meglumine in TALICA sustained release capsules based on high performance liquid chromatography(HPLC).Methods By applying HPLC method,the Agilent ZORBAX SB-C18 chromatographic column(150 mm×4.5 mm,5 μm)was used.The mobile phases were acetonitrile(A)-phosphate buffer(B)and acetonitrile(A)-heptane sodium sulfonate buffer(B),respectively,and the elution was gradient according to a time program.Using VWD detector,the detection wavelengths were 254 nm and 195 nm,respectively.Injection volume was 10 μL and 20 μL,respectively.The flow rate was 1 mL·min-1.The column temperatures were 26℃and 35℃,respectively.By external standard method,the content of three principal components of amoxicillin,omeprazole magnesium,rifabutin and meglumine excipients was calculated.Results At 254 nm,there was a good linear relationship between amoxicillin,omeprazole magnesium,and rifabutin in the mass concentrations of 0.02-2.12,0.02-2.16,0.02-2.16 mg·mL-1,respectively(r>0.999 7).The average recoveries were 99.5%,98.9%and 99.6%,and RSD were 0.5%,1.1%and 0.6%,respectively.The mark percentage content of the three principal components were 98.8%-101.1%.At 195 nm,meglumine showed a good linear relationship within the mass concentration of 1.00-50.00 mg·mL-1(r=0.999 9).The average recovery and RSD were 100.8%and 0.9%,and the average content of meglumine was 6.6%.Conclusion The HPLC method for the determination and analysis of the content of amoxicillin,omeprazole magnesium,rifabutin and meglumine in TALICA sustained release capsules is stable,straightforward and dependable,which can offer the basis for the study of quality control of TALICA sustained release capsules.
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