摘要
Objective To compare the content, uniformity of dosage units and dissolution rate of triphasic oral contraceptives from two pharmaceutical factories A and B. Methods A High Performance Liquid Chromatography （HPLC） method for the simultaneous determination of levonorgestrel and ethinylestradiol was used. The content of levonorgestrel （LNG） was monitored by an UV detector at 247 nm, while ethinylestradiol （EE） was monitored by fluorescence detector with the excitation of 285 nm and emission wavelengths of 310 nm. The dissolution test was performed using the paddle method. Results The content of levonorgestrel （LNG） and ethinylestradiol （EE） in product A was within 100.5%-122.4% while product B within 120.6%-140.9%. The uniformity value of dosage units of tablets from two factories was more than 15. The dissolution rate of tables from two factories was more than 60% within 60 min. Conclusion Only the content of product A was in the ±25% range of label claim. The uniformity of two products was not up to standard. The dissolution rate of the tablets from two products met the requirement of ChP2005.
Objective To compare the content, uniformity of dosage units and dissolution rate of triphasic oral contraceptives from two pharmaceutical factories A and B. Methods A High Performance Liquid Chromatography （HPLC） method for the simultaneous determination of levonorgestrel and ethinylestradiol was used. The content of levonorgestrel （LNG） was monitored by an UV detector at 247 nm, while ethinylestradiol （EE） was monitored by fluorescence detector with the excitation of 285 nm and emission wavelengths of 310 nm. The dissolution test was performed using the paddle method. Results The content of levonorgestrel （LNG） and ethinylestradiol （EE） in product A was within 100.5%-122.4% while product B within 120.6%-140.9%. The uniformity value of dosage units of tablets from two factories was more than 15. The dissolution rate of tables from two factories was more than 60% within 60 min. Conclusion Only the content of product A was in the ±25% range of label claim. The uniformity of two products was not up to standard. The dissolution rate of the tablets from two products met the requirement of ChP2005.
基金
funded by the National Tenth Five-year Key Project "the Study on Contraceptives Safety Surveillance and Evaluation (No.2004BA72032)"
the National Eleventh Five-year Key Project "Study on Post-market Surveillance and Risk Reevaluation for Contraceptives (No.2006BAI15B07)"
