ABSTRACT
Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets. Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia (ChP) 2015. In total 500 ml of 0.05% sodium lauryl sulfate solution was used as dissolution media, and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18 column (150 mm×4.6 mm, 5 µm). The mobile phase: acetonitrile as mobile phase A, acetonitrile-water (50:50, V/V) as mobile phase B with gradient elution. The flow rate was 1 ml/min. The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40 and the injection volume was 100 µl. Results The average recoveries were 99.68% for desogestrel and 99.40% for ethinylestrsdiol, and the stability of working solutions was acceptable in 12 h. The calibration curves were linear within the range of(0.06-0.36)µg/ml (r=0.9999)for desogestrel, (0.012-0.072)µg/ml (r=0.9999)for ethinylestradiol, respectively. Conclusion The method is convenient and precise in the dissolution determination of desogestrel and ethinylestradiol tablets.
ABSTRACT
Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets. Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia(ChP)2015. In total 500 ml of 0.05%sodium lauryl sulfate solution was used as dissolution media,and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18 column(150 mm×4.6 mm,5μm). The mobile phase:acetonitrile as mobile phase A,acetonitrile-water(50∶50,V/V)as mobile phase B with gradient elution. The flow rate was 1 ml/min. The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40℃and the injection volume was 100μl. Results The average recoveries were 99.68%for desogestrel and 99.40%for ethinylestrsdiol,and the stability of work?ing solutions was acceptable in 12 h. The calibration curves were linear within the range of(0.06-0.36)μg/ml(r=0.9999)for desoges?trel,(0.012-0.072)μg/ml(r=0.9999)for ethinylestradiol,respectively. Conclusion The method is convenient and precise in the dis?solution determination of desogestrel and ethinylestradiol tablets.
ABSTRACT
Objective To observe the clinical efficacy and adverse reactions of desogestrel ethinylestradiol in the treatment of dysfunctional uterine bleeding ( adolescent Dub ) .Methods 86 cases with adolescent functional bleeding were divided into the treatment group and control group ,43 cases in each group .The control group received conjugated estrogen(Premarin) treatment,the treatment group was given desogestrel ethinylestradiol treatment .The hemostatic effect and drug adverse reaction of the two groups were observed .Results The cure rate of the treatment group was 65.1%,that in the control group was 23.3%,there was significant difference between the two groups (χ2 =15.28,P0.05).Conclusion Desogestrel ethinylestradiol in the treatment of ado-lescent functional bleeding has exact curative effect ,it has low incidence of adverse reactions and better acceptance .
