Abstract
Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection such as the common cold and flu. Here we were reporting a simple and precise validated stability indicating RP-HPLC method for estimation of Pseudoephedrine Sulfate and its related compounds in solid oral dosage forms. The stability indicating nature of current method has been demonstrated by a forced degradation study. All process related impurities and degradation products from forced degradation samples were well resolved from each other. The chromatographic separation of impurities was achieved with a Hypersil phenyl column (25 cm x 4.6 mm i.d., particle size 5 μ) using buffer and acetonitrile in the ratio of 95:5 v/v respectively as the mobile phase. The buffer used in mobile phase contained 10 mM potassium dihydrogen phosphate and its pH was adjusted to 3.0 ±0.05 with diluted orthophosphoric acid. The flow rate of HPLC was 1.0 mL min−1 and the wavelength of UV detector at 210 nm. The method was shown a linear response over range of 0.125 μg mL−1 to 0.750 μg mL−1 PES and impurities. The correlation coefficient was more than 0.999. Performed the robustness by using design experiments.
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