Levonorgestrel Tablets
Action and use
Progestogen.
DEFINITION
Levonorgestrel Tablets contain Levonorgestrel.
Content of levonorgestrel, C21H28O2
95.0 to 105.0% of the stated amount.
IDENTIFICATION
50 volumes of methanol and 50 volumes of a 1% w/v solution of gamma-cyclodextrin.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to dextronorgestrel and levonorgestrel and is at least 1.0.
The principal peak in the chromatogram obtained with solution (1) has the same retention time as the peak due to levonorgestrel in the chromatogram obtained with solution (2).
Tests
Dissolution
For tablets containing less than 100 µg of levonorgestrel
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
50 volumes of acetonitrile and 50 volumes of water.
The test is not valid unless, in the chromatogram obtained with solution (2), the column efficiency, determined on the peak due to levonorgestrel is at least 5000 theoretical plates per metre.
Calculate the total content of C21H28O2 in the medium from the chromatograms obtained and using the declared content of C21H28O2 in levonorgestrel BPCRS.
For tablets containing 100 µg or more of levonorgestrel
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Dissolution (For tablets containing less than 100 µg of levonorgestrel) may be used with an injection volume of 25 µL.
The test is not valid unless, in the chromatogram obtained with solution (2), the column efficiency, determined on the peak due to levonorgestrel is at least 5000 theoretical plates per metre.
Calculate the total content of C21H28O2 in the medium from the chromatograms obtained and using the declared content of C21H28O2 in levonorgestrel BPCRS.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in methanol (50%).
100 volumes of methanol, 240 volumes of acetonitrile and 500 volumes of water.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to ethinylestradiol and levonorgestrel is at least 12.0.
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);
the sum of the areas of any such peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%).
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Levonorgestrel comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Dissolution (For tablets containing less than 100 µg of levonorgestrel) may be used with an injection volume of 25 µL.
50 volumes of acetonitrile and 50 volumes of water.
The test is not valid unless, in the chromatogram obtained with solution (2), the column efficiency, determined on the peak due to levonorgestrel is at least 5000 theoretical plates per metre.
Calculate the content of C21H28O2 in each tablet using the declared content of C21H28O2 in levonorgestrel BPCRS.
ASSAY
Use the average of the individual results determined in the test for Uniformity of content.