Development and Validation of A UV Spectroscopic Method for Analysis of Paracetamol in Bulk Powder and Tablet

Abstract

INTRODUCTIONParacetamol or acetaminophen is active metabolites of phenacitin. It is a widely used overthe counter analgesic and antipyretic. Chemically, it is 4-hydroxy acetanilide (acetaminophen) 1 . Paracetamol and other NSAIDs all act by the same mechanism (inhibition of prostaglandin synthesis by inhibiting cyclooxygenase (COX)) and all show varying levels of analgesic, anti-inflammatory, antipyretic and anti-platelet actions 2-3 . Paracetamol is official in Indian Pharmacopoeia and British Pharmacopoeia. Both compendia suggest titrimetric and UV spectrophotometric assay method for paracetamol in bulk and tablet formulations. ORIENTAL JOURNAL OF CHEMISTRY ABSTRACTThe method has been developed and validated for the assay of Paracetamol using mixed solution of methanol and phosphate buffer 6.8 as a solvent in ratio of (1:3) (further diluted in phosphate buffer 6.8 only). The λ max (absorption maxima) of the drug was found to be 246 nm. Linear response was observed in the range of 2-24ìg/ml with a regression coefficient of 0.999. Furthermore various validation parameters as per ICH Q2B guideline were tested and found accordingly. The method and solution was significantly (P<0.05) stable for 15 days. The percent purity (99.09 %) and % Recovery at 80, 100 and 120 % were found to be 102.00±2.027, 102.10±4.913 and 100.00±4.819 respectively for marketed paracetamol tablets. Developed method was a less toxic, cheap, eco-friendly but equally sensitive spectroscopic method for quantitative determination of paracetamol for regular quality control purpose in laboratories.

Application of Similarity Factor (f2) and Time Required to Drug Release (t%) Indicators for Dissolution Profiles Comparison of Paracetamol Tablets

“…13 Published protocols were followed with slight modifications to prepare a calibration curve of paracetamol in a concentration range between 5.0 and 25.0 µg/mL using 0.1 M NaOH as a medium. 14,15 The absorbance values were measured in triplicate using UV/Visible-spectrophotometer at a wavelength (λ) of 255.6 nm. The method was validated in terms of linearity, range, precision and accuracy using three known concentrations of paracetamol solutions (5.0, 15.0 and 25.0 µg/mL).…”