Pharmaceutical Regulatory Affairs: Open Access

UPLC Analytical Method Development and Validation for the Simultaneous Estimation of Paracetamol and Caffeine Capsules Dosages Form

Abstract

Bikash Ranjan Jena, Sitty Manohar Babu, Debi Prasad Pradhan and Suryakanta Swain

In the present study, a rapid, an accurate and precise Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for simultaneous estimation of paracetamol and caffeine in its capsule dosage form (325 mg and 30 mg) by selecting chromatographic parameters. The UPLC method was developed using 2.1 × 50 mm, reverse phase C₁₈ column (Acquity UPLC ethylene bridge hybrid (BEH) C₁₈ 1.7 μm) with mobile phases containing 0.1% w/v H₃PO₄ and 100% v/v buffer as mobile phase A and methanol: Acetonitrile (50:50) as mobile phase B and water: acetonitrile: H₃PO₄ (80:20:0.1) as diluent and the run considered as an isocratic elution. Flow rate was 0.5 ml/min with PDA detection at (λ_max) 275 nm for paracetamol and caffeine and the injection volume was set at 2 μL with run time 7 min. The method was validated by using various validation parameters like accuracy, precision, linearity and specificity. These results show the method could find practical application as a quality control tool for analysis of the drug in its capsule dosage forms in pharmaceutical industries. The developed validated method and stability testing of new dosage forms as per ICH-Q2 (R1) and ICH-Q1C guidelines applicable for the analysis of bulk drug and in its capsules dosage form.