RP-HPLC-Based Quantitative Analysis of Multi-Component Antineoplastic Dosage Forms: Method Development and Validation

  • Unique Paper ID: 204690
  • Volume: 13
  • Issue: 1
  • PageNo: 3372-3375
  • Abstract:
  • A simple, precise, accurate, and robust reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Cisplatin and Etoposide in combined antineoplastic dosage forms. Chromatographic separation was achieved using an Inertsil C18 column with a mobile phase consisting of methanol and phosphate buffer (pH 3.0) in the ratio of 70:30 v/v. Detection was carried out at 260 nm with a flow rate of 0.8 mL/min. The retention times for Cisplatin and Etoposide were found to be approximately 2.57 and 3.84 min, respectively. The developed method was validated according to ICH Q2(R1) guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The correlation coefficients were found to be greater than 0.999 for both analytes. Percentage recovery ranged from 98–102%, indicating excellent accuracy. The developed method was found to be suitable for routine quality-control analysis of Cisplatin and Etoposide in pharmaceutical dosage forms. The method demonstrated excellent reproducibility, sensitivity, and reliability for simultaneous estimation of both drugs. The study confirms the applicability of the developed RP-HPLC method for regular analytical and industrial quality assurance purposes.

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{204690,
        author = {S Haritha},
        title = {RP-HPLC-Based Quantitative Analysis of Multi-Component Antineoplastic Dosage Forms: Method Development and Validation},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3372-3375},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204690},
        abstract = {A simple, precise, accurate, and robust reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Cisplatin and Etoposide in combined antineoplastic dosage forms. Chromatographic separation was achieved using an Inertsil C18 column with a mobile phase consisting of methanol and phosphate buffer (pH 3.0) in the ratio of 70:30 v/v. Detection was carried out at 260 nm with a flow rate of 0.8 mL/min. The retention times for Cisplatin and Etoposide were found to be approximately 2.57 and 3.84 min, respectively. The developed method was validated according to ICH Q2(R1) guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The correlation coefficients were found to be greater than 0.999 for both analytes. Percentage recovery ranged from 98–102%, indicating excellent accuracy. The developed method was found to be suitable for routine quality-control analysis of Cisplatin and Etoposide in pharmaceutical dosage forms. The method demonstrated excellent reproducibility, sensitivity, and reliability for simultaneous estimation of both drugs. The study confirms the applicability of the developed RP-HPLC method for regular analytical and industrial quality assurance purposes.},
        keywords = {RP-HPLC, Cisplatin, Etoposide, Method Validation, Antineoplastic Agents, ICH Guidelines.},
        month = {June},
        }

Cite This Article

Haritha, S. (2026). RP-HPLC-Based Quantitative Analysis of Multi-Component Antineoplastic Dosage Forms: Method Development and Validation. International Journal of Innovative Research in Technology (IJIRT), 13(1), 3372–3375.

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