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ISSN 2063-5346
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Stability Indicating Analytical Method for Simultaneous Estimation of Assay of Ibuprofen, Domiphen Bromide and Related Substances of Ibuprofen in Finished Formulation by UPLC

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Suresh Reddy Yelampalli, Mercy Anvitha Kamireddy , Deepti Kolli , Madhusudhana Reddy Nimmakayala , B. Raj Kumar , Chandaka madhu, Konatham Teja Kumar Reddy
» doi: 10.31838/ecb/2023.12.si4.081

Abstract

To develop and validate a simple, fast, precise, selective and accurate UPLC method to determine the assay of Ibuprofen, Domiphen Bromide and Ibuprofen impurities in Ibuprofen suspension. Chromatographic separation has achieved on AQUITY UPLC BEH C18 column (2.1×100 mm), 1.7 µ particle size using mobile phase A as 0.1 % Ortho phosphoric acid and mobile phase B as 100 % Acetonitrile. The flow rate was 0.4 ml/min and detection wavelength carried out at 215 nm. The retention time of Ibuprofen, 4-Isobutyl acetophenone (Related Compound-C) and Domiphen Bromide was found 5.4 min, 6.5 min and 10.1 min respectively. The method has been developed and validated according to ICH guidelines. Ibuprofen, Domiphen Bromide and related impurities are completely separated with each other and with blank and placebo peaks. The linear range of Ibuprofen was 0.1 ppm to 750 ppm, Domiphen Bromide was 0.25 ppm to 3.75 ppm and 4-Isobutyl acetophenone was 0.24 ppm to 1.92 ppm. The recovery of Ibuprofen, Domiphen Bromide and 4-Isobutyl acetophenone were found in between 95.0 % to 105.0 %. The obtained cumulative % RSD of precision and intermediate precision study is 0.1 and 1.9 for Ibuprofen, 0.3 and 1.8 for Domiphen Bromide, 1.4 and 1.5 for 4-Isobutyl acetophenone. The developed method was precise, accurate and linear. It can be used for the testing for assay of Ibuprofen and Domiphen Bromide and Ibuprofen related substances in Ibuprofen suspension 100 mg/5 ml during routine quality control and stability testing.

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