Chlordiazepoxide Tablets
Action and use
Benzodiazepine.
Definition
Chlordiazepoxide Tablets contain Chlordiazepoxide Hydrochloride.
Content of chlordiazepoxide, C16H14ClN3O
95.0 to 105.0% 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.
After 45 minutes withdraw a sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 308 nm, Appendix II B using 0.1m hydrochloric acid in the reference cell.
Calculate the total content of chlordiazepoxide, C16H14ClN3O, in the medium taking 327 as the value of A(1%, 1 cm) at the maximum at 308 nm.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use and protected from light.
Equal volumes of acetonitrile and water.
The test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to impurity A and chlordiazepoxide is at least 5.0.
When the chromatograms are recorded under the prescribed conditions the retention times relative to chlordiazepoxide (retention time about 3.6 min) are impurity A, about 0.7 and aminochlorobenzophenone, about 3.9.
In the chromatogram obtained with solution (1):
the area of any peak due to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (3%);
the area of any peak due to aminochlorobenzophenone is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);
the sum of all impurities is not greater than 3.4%.
Disregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).
Assay
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use and protected from light.
The chromatographic conditions described under Related substances may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity A and chlordiazepoxide is at least 5.0.
Calculate the content of C16H14ClN3O in the tablets using the declared content of C16H14ClN3O,HCl in chlordiazepoxide hydrochloride BPCRS. Each mg of C16H14ClN3O,HCl is equivalent to 0.8916 mg of C16H14ClN3O.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of chlordiazepoxide.