Computerized gas-liquid chromatographic method for content uniformity analysis of dicyclomine hydrochloride capsules...

An automated, computerized method is presented for the content uniformity determination of dicyclomine hydrochloride capsules and tablets, using up to 4 automatic sampler-equipped gas chromatographs interfaced with a minicomputer. A 3% OV-17 column is used with anthracene as an internal standard. Five sample injections are bracketed by standard mixtures containing about 90 and 110% of the labeled dicyclomine hydrochloride. Data are taken on-line simultaneously from each gas chromatograph and a computer-generated report is produced. Calculations use a BASIC program with linear fit of the 90 and 110% standard mixture. Individual tablet or capsule results are printed in milligrams and per cent declared, including summary calculations of average, high, low, standard deviation, and coefficient of variation. The GLC results are comparable (within 1%) to those obtained using the USP procedure.