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| Determination of related substances and the content of gestodene sustained release contraception microneedles |
| 1.Centre of Drug and Medical Polymer Materials, Nationals Research Institute for Family Planning, Beijing, 100081; 2. Graduate School of Peking Union Medical College; 3. Key Laboratory of Photochemical Conversion and Optoelectronic Materials，Technical Institute of Physics and Chemistry，Chinese Academy of Sciences |
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Abstract Objective: To establish a HPLC method for determing of the content and related substances of gestodene in sustained release contraception microneedles. Methods: The chromatographic conditions of the HPLC method, Diamonsil C18 column (250 mm × 4.6 mm, 5 μm), the mobile phase consisted of acetonitrile and water (55:45, v/v) at the flow rate of 1 ml/min, detection wavelength was 239 nm. Results: The results of specific tests showed that the blank accessories did not interfere with the determination of the main drug. Gestodene and impurities, degradation products could achieve a good separation. The calibration curve of gesterdene had acceptable linearity in the range of 0.5-20 μg/ml.The limit of quantification and detection of gestodene were 7.5ng/ml and 2.5ng/ml, respectively. The average recovery was 98.4%. The determination method of this content was good in precision, stability and repeatability. Conclusion: This method has the advantages of strong specificity, accuracy, good reproducibility and simple operation, which can be used for quality control of gestodene sustained release contraception microneedls.
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