Clomifene Tablets
Action and use
Estrogen receptor modulator.
Definition
Clomifene Tablets contain Clomifene Citrate.
Content of clomifene citrate, C26H28ClNO,C6H8O7
92.5 to 107.5% of the stated amount.
Identification
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of clomifene citrate, C26H28ClNO,C6H8O7, in the medium taking 317 as the value of A(1%, 1 cm) at the maximum at 232 nm.
Z-Isomer
Carry out the method for liquid chromatography, Appendix III D, using the following solution.
A mixture of ethanol-free chloroform and hexane, each containing 0.10% v/v of triethylamine, adjusted so that baseline separation is obtained between E- and Z-clomifene (20 volumes of ethanol-free chloroform and 80 volumes of hexane is usually suitable).
The test is not valid unless baseline separation is achieved between E- and Z-clomifene and the column efficiency is greater than 10,000 theoretical plates per metre determined using the peak due to the E-isomer.
30.0 to 50.0% of the content of clomifene citrate as determined in the Assay.
Calculate the percentage of Z-isomer from the expression 100AZ/(1.08AD+ AZ) where AZ and AD are the areas of the peaks due to the Z- and E-isomers, respectively.
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing 50 mg of Clomifene Citrate for 30 minutes with 70 mL of 0.1m hydrochloric acid prepared using a 30% v/v solution of propan-2-ol as solvent, dilute to 100 mL with the propanolic hydrochloric acid and filter. Dilute 5 mL of the filtrate to 100 mL with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 292 nm, Appendix II B, using in the reference cell a solution prepared by diluting 5 mL of the propanolic hydrochloric acid to 100 mL with 0.1m hydrochloric acid. Calculate the content of C26H28ClNO,C6H8O7 taking 175 as the value of A(1%, 1 cm) at the maximum at 292 nm.
Storage
Clomifene Tablets should be protected from light.