Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF THREE COMBINATION DRUGS PARACETAMOL, CETIRIZINE AND PSEUDOEPHEDRINE BY RP-HPLC AND ITS APPLICATION IN ASSAY OF TABLET DOSAGE FORMS

Shree Narayan Pandit*, Anirbandeep Bose, Divakar Goli, Gurubasavarajswamy, Sabyasachi Mandal, Sowparnika

ABSTRACT

A RP-HPLC method was developed for simultaneous estimation of Paracetamol (PCM), Cetirizine (CTZ) and Pseudoephedrine (PSEDN) for bulk drug and marketed tablet formulation using Phenomenex Luna C18 column (250 mm × 4.6 mm id, 5 μm) and a mobile phase of Acetonitrile: 0.025 mM Potassium Dihydrogen orthophosphate + one drop of Triethylamine in every 100 ml of buffer solution pH 7.5, 50:50 v/v, at flow rate 0.5 ml/min with UV detection at 220 nm. The retention time (tR) of Paracetamol, Cetirizine and Pseudoephedrine were found to be 5.706, 8.097 and 4.848 respectively. The proposed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ and robustness. All parameters were found to be with in the acceptance limit.Linearity for Paracetamol was in the range of 75-600 μg/ml, Cetirizine was in the range of 2.5-20 μg/ml and Pseudoephedrine was in the range of 5-40 μg/ml. LOD and LOQ values were found to be less than 2.2 μg/ml level proving their sensitiveness towards the developed method.HPLC methods were simple, accurate, precise and suitable for analysis of marketed tablet formulation containing Paracetamol, Cetirizine and Pseudoephedrine.

Keywords: RP-HPLC Method, UV Spectroscopy, Paracetamol, Cetirizine and Pseudoephedrine.