A SIMPLE STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF LEVOCETIRIZINE DIHYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND PARACETAMOL IN PHARMACEUTICALS

摘要

An accurate and precise HPLC method was developed and validated for simultaneous determination of Levocetirizine dihydrochloride, Phenylephrine hydrochloride and Paracetamol in syrup formulations. The separation between Levocetirizine dihydrochloride, Phenylephrine hydrochloride, and Paracetamol was achieved within 20 min using an L1 column of 100 × 4.6 mm, 3 μ dimension using gradient programme and detector wavelength 215 nm. The mobile phase solution A is a buffer solution of 0.015 Molar 1-octane sulphonic acid sodium salt adjusted pH 3.4 with orthophosphoric acid and mobile phase solution B is Acetonitrile. The Method was validated as per ICH guideline for parameters like Specificity, Precision, Accuracy, solution stability, filter compatibility, and robustness. Accuracy for Levocetirizine dihydrochloride, Phenylephrine hydrochloride, and Paracetamol lies between 97.0 to 103.0%. The proposed method can be used for quality control assay of Levocetirizine dihydrochloride, Phenylephrine hydrochloride and Paracetamol in pharmaceuticals.