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Automated stability-indicating high-performance liquid chromatographic assay for ethinyl estradiol and
V D Reif1, W M Eickhoff, J K Jackman
1Analytical Research and Development Division, Wyeth Laboratories, Inc., Philadelphia, Pennsylvania 19101.
Pharmaceutical Research
|February 1, 1987
Summary
A new automated high-performance liquid chromatography (HPLC) method accurately analyzes ethinyl estradiol and levonorgestrel in oral contraceptives. This validated assay is efficient for routine quality control testing of these essential pharmaceutical products.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Oral contraceptives require precise quantification of active pharmaceutical ingredients for efficacy and safety.
- Existing analytical methods may lack the automation and efficiency needed for high-throughput pharmaceutical quality control.
Purpose of the Study:
- To develop and validate an automated high-performance liquid chromatography (HPLC) assay for simultaneous determination of ethinyl estradiol and norgestrel/levonorgestrel in oral contraceptive tablets.
- To establish a robust method for content uniformity and stability testing.
Main Methods:
- Utilized a solid sampler and segmented continuous flow techniques for automated sample preparation and on-line injection.
- Employed reversed-phase C8 and C18 columns with a water-acetonitrile-methanol mobile phase for separation.
- Integrated UV and fluorescence detection for sensitive and selective quantification of the active components.
Main Results:
- Successfully separated ethinyl estradiol and levonorgestrel from excipients, impurities, and degradation products.
- Achieved simultaneous detection using a combination of UV absorbance and fluorescence detection.
- Demonstrated applicability for content uniformity and stability testing at a rate of eight samples per hour.
Conclusions:
- The developed automated HPLC assay provides an efficient and reliable method for analyzing oral contraceptive tablets.
- This method is suitable for routine quality control, ensuring the consistency and stability of ethinyl estradiol and levonorgestrel formulations.