DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND ONDANSETRON IN LUPISETRON-PLUS TABLET DOSAGE FORM

Paracetamol (PCM) is the inhibition of cyclooxygenase (COX) and recent findings suggest that it is highly selective for COX-2 and used for headache, low backache. Ondansetron (OND) is a selective serotonin 5-HT2 receptor antagonist used in nausea, nausea and vomiting due to chemotherapy. A reversed phase high performance liquid chromatographic method was developed and validated for simultaneous estimation of Paracetamol and Ondansetron in tablet dosage form. The chromatographic separation was achieved using BDS hypersil C18 column (250 mm, 4.6 mm i.d., 5 μm) as stationary phase & Phosphate Buffer pH 5.5 : ACN (40:60 V/V). Detection was carried out at 297 nm. The average retention time for PCM and OND were found to be 3.727 and 6.037min. Linearity for PCM and OND were observed in the concentration range from 62.5-187.5 μg/ml (r2 = 0.999) and 0.5-1.5 μg/ml (r2 = 0.988). Accuracy of the method was studied by the recovery studies at three different levels 80%, 100% and 120% level. The recovery was found to be within the limits of acceptance criteria with average recovery of 99.62 – 99.87% for PCM and 100.32 – 100.62% for OND. The high precision of proposed method is confirmed by % RSD below 2.0 for repeatability. The proposed simple, accurate and pricise RP-HPLC method was successfully applied for determination of PCM and OND from Lupisetron-Plus tablet dosage form for routine analysis.