RP-HPLC Stability Indicating Method Development and Validation of Pseudoephedrine Sulfate and Related Organic Impurities in Tablet Dosage Forms, Robustness by QbD Approach

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.

GRAPHICAL ABSTRACT

Key words:

• RP-HPLC
• pseudoephedrine sulfate
• method development
• validation