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Abstract
In anticipation of the Content Uniformity requirements for USP XVIII and NF XIII, we developed a general procedure for the assay of intact capsules containing a variety of drugs. Using this procedure, whole capsules are dissolved in an appropriate aqueous medium and the drug dialyzed into a suitable recipient stream. The dialyzate is diluted if necessary, and then pumped to a spectrophotometer for final reading and assay. The use of this technique completely eliminates the need for opening capsules and making quantitative transfers of the drug contents.
This technique was so successful that it was extended to tablets containing both water-soluble and water-insoluble drugs. Water-insoluble drugs such as steroids are handled by conducting the dialysis from aqueous alcoholic solutions. Excellent results have been obtained using this technique on chemically dissimilar compounds; examples of these assays will be given.