RP-HPLC Method development, validation for simultaneous estimation of Paracetamol and Mefenamic acid in bulk and its pharmaceutical formulations

  • Unique Paper ID: 174665
  • PageNo: 843-850
  • Abstract:
  • The quantitative analysis of Paracetamol and Mefenamic acid in pharmaceutical dosage form has been accomplished by the development of a straightforward, quick, accurate, sensitive, and repeatable reverse phase high performance liquid chromatography (RP-HPLC) method. Paracetamol and mefenamic acid were separated chromatographically on a Shimadzu LC-20AD using a SHISEIDO C18 (250 x 4.6 mm I.D., 5µm) column, mobile phase A (which contained ACN and methanol in a 90:10 ratio), and mobile phase B (which contained 0.1% orthophosphoric acid and ACN in a 35:65 ratio). 1.0 ml/min was the flow rate; a photodiode array detector operating at room temperature was used to detect absorbance at 213 and 230 nm. Paracetamol and mefenamic acid were found to have retention durations of 2.695 and 5.026 minutes, respectively. The correlation coefficients (r2) for paracetamol and mefenamic acid were 0.9935 and 0.9932, respectively, and linearity was found for both medications in the range of 3.25–16.25µg/ml and 5–25µg/ml. The percentage RSDs for paracetamol and mefenamic acid, respectively, were determined to be 10.73 and 5.45. According to intra- and inter-day accuracy assessments, the relative standard deviation (%RSD) of the suggested approaches was less than the upper limit of 2.0. In compliance with ICH guidelines, the suggested approach was validated. The technique for quantitative analysis of Paracetamol and Mefenamic acid in bulk drugs and pharmaceutical formulations was determined to be straightforward, affordable, appropriate, precise, accurate, and robust.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{174665,
        author = {Ms M Sangeetha and Ms M Prasanna Lakshmi and Ms A.B.T.Maha Lakshmi and Ms A Divya and Mr A Durga Prasad and Mr P Komal Krishna and Mrs T Yamini Kumari and Mr K Sumanth},
        title = {RP-HPLC Method development, validation for simultaneous estimation of Paracetamol and Mefenamic acid in bulk and its pharmaceutical formulations},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {11},
        number = {11},
        pages = {843-850},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=174665},
        abstract = {The quantitative analysis of Paracetamol and Mefenamic acid in pharmaceutical dosage form has been accomplished by the development of a straightforward, quick, accurate, sensitive, and repeatable reverse phase high performance liquid chromatography (RP-HPLC) method.
Paracetamol and mefenamic acid were separated chromatographically on a Shimadzu LC-20AD using a SHISEIDO C18 (250 x 4.6 mm I.D., 5µm) column, mobile phase A (which contained ACN and methanol in a 90:10 ratio), and mobile phase B (which contained 0.1% orthophosphoric acid and ACN in a 35:65 ratio). 1.0 ml/min was the flow rate; a photodiode array detector operating at room temperature was used to detect absorbance at 213 and 230 nm. Paracetamol and mefenamic acid were found to have retention durations of 2.695 and 5.026 minutes, respectively. The correlation coefficients (r2) for paracetamol and mefenamic acid were 0.9935 and 0.9932, respectively, and linearity was found for both medications in the range of 3.25–16.25µg/ml and 5–25µg/ml. The percentage RSDs for paracetamol and mefenamic acid, respectively, were determined to be 10.73 and 5.45.    
According to intra- and inter-day accuracy assessments, the relative standard deviation (%RSD) of the suggested approaches was less than the upper limit of 2.0. In compliance with ICH guidelines, the suggested approach was validated. The technique for quantitative analysis of Paracetamol and Mefenamic acid in bulk drugs and pharmaceutical formulations was determined to be straightforward, affordable, appropriate, precise, accurate, and robust.},
        keywords = {},
        month = {March},
        }

Cite This Article

Sangeetha, M. M., & Lakshmi, M. M. P., & Lakshmi, M. A., & Divya, M. A., & Prasad, M. A. D., & Krishna, M. P. K., & Kumari, M. T. Y., & Sumanth, M. K. (2025). RP-HPLC Method development, validation for simultaneous estimation of Paracetamol and Mefenamic acid in bulk and its pharmaceutical formulations. International Journal of Innovative Research in Technology (IJIRT), 11(11), 843–850.

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