Procedure for content uniformity
[NOTEUse low-actinic glassware in this procedure.
]Transfer the contents of 1Capsule to a 200-mLvolumetric flask,dissolve in and dilute with water to volume,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the filtrate quantitatively and stepwise with 0.1Nhydrochloric acid to obtain a solution having a concentration of about 6µg of chlordiazepoxide hydrochloride per mL.Dissolve a suitable quantity of
USP Chlordiazepoxide Hydrochloride RS,accurately weighed,in 0.1Nhydrochloric acid to obtain a Standard solution having a known concentration of about 6µg per mL.Concomitantly determine the absorbances of the two solutions in 1-cm cells at the wavelength of maximum absorbance at about 245nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C
16H
14ClN
3O·HCl in the Capsule by the formula:
(T/D)C(AU/AS),
in which
Tis the labeled quantity,in mg,of chlordiazepoxide hydrochloride in the Capsule,
Dis the concentration,in µg per mL,of chlordiazepoxide hydrochloride in the test solution,based on the labeled quantity per Capsule and the extent of dilution,
Cis the concentration,in µg per mL,of
USP Chlordiazepoxide Hydrochloride RSin the Standard solution,and
AUand
ASare the absorbances of the solution from the contents of the Capsule and the Standard solution,respectively.