title: High-performance liquid chromatographic analysis of docusate sodium in soft gelatin capsules.
abstract: A rapid and simple high-performance liquid chromatographic (HPLC) method for the analysis of docusate sodium in soft gelatin capsules was developed with progesterone as the internal standard. The method requires a reversed-phase column and a paired-ion technique to separate docusate sodium from other components. A C22 column was used with a mobile phase of acetonitrile:water (70:30) containing 0.005 M tetrabutylammonium phosphate. The flow rate was 1.8 mL/min, and the effluent was monitored at 214 nm. Docusate sodium and progesterone had retention times of 4.5 and 6.8 min, respectively. The proposed HPLC method is linear, accurate, and precise. A mean assay value of 99.6% was obtained by the proposed method when five samples, each containing a composite of 10 capsules, were analyzed. The results obtained by the proposed HPLC, tetra-n-butylammonium iodide titration, and USP XXII HPLC methods are compared.
authors.affiliation: Product Development, R. P. Scherer North America, St. Petersburg, FL 33716.
authors.forename: D R
authors.initials: DR
authors.lastname: Hogue
authors.forename: J A
authors.initials: JA
authors.lastname: Zimmardi
authors.forename: K A
authors.initials: KA
authors.lastname: Shah
mesh_terms: D002138:Calibration; D002214:Capsules / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D004143:Dioctyl Sulfosuccinic Acid / Q000032:analysis*; D005780:Gelatin / Q000032:analysis*; D000644:Quaternary Ammonium Compounds
chemical_list: D002214:Capsules; D000644:Quaternary Ammonium Compounds; D004143:Dioctyl Sulfosuccinic Acid; D005780:Gelatin; C009405:tetrabutylammonium