Validation of HPLC-DAD method for analysis of paracetamol and potassium sorbate in liquid oral formulations and its application to forced degradation study

• DOI: 10.1556/1326.2024.01215
• Publication Date: 2024-04-29T09:02:39Z
• Authors: Mira Mikulić; Darija Sazdanić; Nebojša Kladar; Jovana Radulović; Branislava Srđeno...; Milica Atanackovi...
• Keywords: Forced degradation; Degradation; Potassium sorbate

Abstract Due to the frequent use of paracetamol formulations, it is useful develop an analytical technique for determination intact in presence other drugs and excipients or degradation products. In this study, a simple, isocratic, fast, specific, accurate precise stability-indicating high performance liquid chromatography (HPLC) method has been developed validated simultaneous quantitative (PCM) potassium sorbate (PS) oral formulations. The chromatographic separation was achieved on Zorbax SB C18 column (150 × 4.6 mm, 5 µm) with precolumn (12.5 using distilled water pH 2 ortho-phosphoric acid acetonitrile (70:30, v/v) as mobile phase, UV detection at 235 nm. temperature kept constant 25 °C. according International Conference harmonization (ICH) guidelines. demonstrated excellent linearity, correlation coefficient 0.9996 0.9998 PCM PS, respectively, over concentration ranges 10–600 μg mL −1 6–500 (PS). retention time found be 1.98 4.86 min respectively. Oral formulation samples were subjected various stress conditions (acidic alkaline hydrolysis, well oxidative, heat photolytic degradation) purpose forced study. major acidic basic conditions, while thermal generally had least influence. On hand, highly susceptible degradation. It also shown that strong influence stability tested compounds. Forced studies power can used assess