Estropipate Tablets
Action and use
Estrogen.
Definition
Estropipate Tablets contain Estropipate.
Content of estropipate, C18H22O5S,C4H10N2
95.0 to 105.0% of the stated amount.
Identification
In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).
Tests
Free estrone
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
35 volumes of acetonitrile and 65 volumes of 0.025m potassium dihydrogen orthophosphate.
The peak due to estrone has a retention time, relative to the peak due to estropipate, of about 5.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to estrone is not greater than the area of the peak in the chromatogram obtained with solution (2) (2%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Estropipate 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 procedure described under Free estrone may be used.
Calculate the content of C18H22O5S,C4H10N2 in each tablet using the declared content of C18H22O5S,C4H10N2 in estropipate BPCRS.
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic procedure described under Free estrone may be used.
Calculate the content of C18H22O5S,C4H10N2 in the tablets using the declared content of C18H22O5S,C4H10N2 in estropipate BPCRS.