Abstract
A stability-indicating assay method for some dicyclomine hydrochloride formulations was developed utilizing capillary gas—liquid chromatography. A methanolic extract of the sample, containing phenacetin as internal standard, was chromatographed by temperature programming on a 15 m × 0.524 mm I.D., DB-17 column with nitrogen carrier gas and flame ionization detection (1 · 10 −10 A). The dicyclomine hydrochloride was well resolved from phenacetin with retention times of ca. 9 and 7 min, respectively. Dicyclomine hydrochloride—internal standard peak area ratio was linear over 0.1–1.0 μg of dicyclomine hydrochloride injected ( r 0.999). Under the experimental conditions the limit of detection was 0.025 μg of dicyclomine hydrochloride injected. Validation studies with synthetic capsules, tablets and injectables covering a range of 5–25 mg of dicyclomine hydrochloride per unit gave an overall percent recovery (± relative standard deviation, n 9) of 99.9 ± 1.7%. The method was successfully applied to the assay of commercial formulations. Stability tests indicated that degradation products of dicyclomine, formed upon acid treatment, did not interfere with the dicyclomine and internal standard peaks. They further showed that dicyclomine is fairly stable in base.
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