Analytical method validation for related substance of acetaminophen soft gelatin capsules by HPLC chromatography study

Acetaminophen is the name most usually used in the United States and Japan, but paracetamol is more
commonly used in other parts of the world, including Europe, Australia, and Asia, which is commonly used
as a pain reliever and fever reducer. The current work sought to create an analytical method for the related
substance of acetaminophen in soft gelatin capsules. The presence of related compounds in acetaminophen
formulations can affect their safety and efficacy. In this study, a high-performance liquid chromatography
(HPLC) approach for detecting related compounds in acetaminophen was devised.The procedure involved
solvent extraction of the material, followed by chromatographic separation on a C8 column with a mobile
phase of 250 ml of methanol, 1.15 g of 40% w/v solution of tetra butyl ammonium hydroxide, 375 ml of
0.05 M disodium hydrogen orthophosphate and 375 ml of 0.05 M sodium dihydrogen orthophosphate. A
PDA detector set to the appropriate wavelength of 245 nm was used for detection. The run time of solutions
2 and 3 was 10 min, and solutions 1, 4, blank, placebo, and spiked sample solutions were 50 min. The
developed approach was validated using ICH criteria for factors such as specificity, accuracy, precision, and
stability. The approach showed high specificity, with resolution between the acetaminophen peak and
related compounds. The new HPLC method was successfully used to analyze genuine acetaminophen samples,
indicating its suitability for routine quality control in pharmaceutical laboratories. This method provides a
dependable means for determining related chemicals in acetaminophen, assuring the safety and efficacy of
pharmaceutical products containing this widely used medication.