STABILITY INDICATING RP-HPLC METHOD FOR COMBINATION OF PSEUDOEPHEDRINE SULPHATE AND LORATADINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION

Reverse Phase – High performance liquid chromatographic (RP – HPLC) method was described for determination of Pseudoephedrine Sulphate (PSE) and Loratadine Hydrochloride (LOR). The chromatographic separation was achieved using mobile phase mixture of Acetonitrile: 0.05 M Potassium Dihydrogen Phosphate Buffer: (pH 2.8 adjusted with Ortho Phosphoric Acid Solution): Methanol in the ratio of 30:35:35 (%v/v/v) with column Zorbax Eclipse XDB C₁₈, (150 x 4.6 mm i.d), Particle size 5 mm at 1.2 ml/min flow rate. 10 µL of standard preparation containing 150 µg/ml PSE and 6.25 µg/ml LOR was injected into the column and the component was separated by carrying out elution for a run time of 10 minutes and detected at 254 nm wavelength. The described method shows excellent linearity over a range of 120 to 180 μg/ml and 5 to 7.5 μg/ml for PSE and LOR, respectively. PSE and LOR were subjected to stress degradation conditions of hydrolysis (acid and base), oxidation, Heat and UV light degradation. Stressed samples were analysed by the developed method. The proposed method was readily applied for the assay of pharmaceutical formulations and the results were found to be accepted, therefore the proposed method can be adopted for the routine analysis of any quality control laboratory.