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Article Title

HPLC analysis of morphine in tablet mixture glycyrrhizin composite

Abstract

For the quality control of morphine content in Tablet Mixture Glycyrrhizin Composite, previously a so called (extraction) method was developed by our bureau. However, this method required acid and base treatments, repeated extraction of the sample with organic solvents, and it took about 60 working-hours. In this study, we have established an HPLC method to determine the morphine content in the product by using an Inertsil 5 ODS-2 colume (4.6 × 150mm), and a mobile phase consisting of 75% 2.5mM sod. 1-dodecane-sulfonate in 1% acetic acid and 25% acetonitrile. In order to compare the HPLC method with extraction method, the morphine content of 10 batches of product was quantified by both methods. The results obtained from both methods were not significantly different. The standard deviations of extraction method and HPLC method were ±1.98% and ±1.94%, respectively. The correlation coefficient(r) of 10 pairs data was 0.8093, showing very significant relationship between two methods in accordance with the r-and t-tests. In addition, the HPLC method reduces the analysis time to 8 hours. These results strongly suggest that the HPLC method is more efficient than the extraction method.

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