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 pairedion technique to separate docusate sodium from other components. A C22 column was used with a mobile phase of acetonitrile: water (70:30) containing 0.005M tetrabutylammonium phosphate. The flow rate was 1.8 mL/min, and the effluent was monitored at 214nm. 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 DSP XXII HPLC methods are compared.
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