Citation: Palled PJ, Dushyanth Reddy V, Mannor VS, et al. Validated Isocratic/Gradient RP-HPLC for Simultaneous Estimation of
Paracetamol Ibuprofen and Caffeine in Marketed Formulations Using Diclofenac as Internal Standard. Anal Chem Ind J. 2017;17(1):116.
© 2017 Trade Science Inc.
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Validated Isocratic/Gradient RP-HPLC for Simultaneous Estimation of
Paracetamol Ibuprofen and Caffeine in Marketed Formulations Using
Diclofenac as Internal Standard
Palled PJ, Dushyanth Reddy V
*
, Mannor VS and Bharat Chowdary
Department of Pharmaceutical Chemistry, KLE's University College of Pharmacy, KLE University Belagavi 590001, India
*
Corresponding author: Dushyanth Reddy V, Department of Pharmaceutical Chemistry, KLE's University College of
Pharmacy, KLE University, Belagavi 590001, India, Tel: 08312471399; E-mail: dushyanthreddy233@gmail.com
Received: October 16, 2016; Accepted: January 16, 2017; Published: January 22, 2017
Introduction
Paracetamol (Acetaminophen) is chemically N-(4-hydroxyphenyl) acetamide is a crystalline solid is a sparingly soluble
compound which is classified under antipyretic analgesics. Drugs Classified under this class possess analgesic and antipyretic
activity but lacks anti-inflammatory effects indicated for use in patients who are sensitive to aspirin with usual adult dosage
325 mcg to 650 mcg dose greater than 2.6 g/day are not advisable for prolonged treatment owing to its hepatotoxicity.
Antipyretic effect of acetaminophen affords to the inhibition of endogenous leukocytic pyrogens released from cells upon
external stimuli or upon activation with exogenous pyrogen. acetaminophen possesses analgesic activity in arthritis and
musculoskeletal disorders.
Abstract
Objective: To develop a validated RP-HPLC method for simultaneous estimation of Paracetamol Ibuprofen and Caffeine.
Methods: The HPLC instrument used was Shimadzu LC-20AD with reverse phase ODS-Hypersil-C18 (250 mm × 4.6 mm, 5 μm)
column using Acetonitrile:water (90:10) pH adjusted to 2.8 as mobile phase. The flow rate was maintained at 0.3 ml/min and UV
detection was carried at 203 nm.
Results: The method was validated for linearity, accuracy, precision, specificity, robustness and ruggedness according to ICH
guidelines. The retention time for Paracetamol, Ibuprofen and Caffeine was found to be 9.7, 12.66 and 10.48 respectively. The
regression analysis showed good linearity over the concentration range of 1.25 μg/ml to 20 μg/ml for paracetamol, 0.625 μg/ml to 10
μg/ml for Ibuprofen and 0.625 μg/ml to 10 μg/ml for Caffeine. The recovery studies of the method gave good results in the range of
99.89% to 100.48% with less than 2% of RSD.
Conclusion: The method was found to be suitable for the analysis of marketed formulation in presence of other excipients.
Keywords: Paracetamol; HPLC; Chromatography; Ibuprofen; Anti-inflammatory