Development And Validation Of Stability-Indicating RP-HPLC Method For Simultaneous Estimation Of Ritonavir And Lopinavir In Tablet Dosage Form

  • Unique Paper ID: 203548
  • Volume: 12
  • Issue: 12
  • PageNo: 11558-11572
  • Abstract:
  • A simple, accurate, precise, and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Ritonavir and Lopinavir in bulk drug and pharmaceutical tablet dosage forms. Chromatographic separation was performed using an XTerra C18 column with a mobile phase consisting of 0.1% orthophosphoric acid buffer (pH 2.8) and methanol (45:55 v/v) at a flow rate of 1.0 mL/min, with detection at 229 nm. The developed method shows good chromatographic separation with satisfactory retention time, peak symmetry, and system suitability parameters. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the stability-indicating capability of the method. Maximum degradation was observed under alkaline conditions. The method was validated according to ICH guidelines for specificity, precision, accuracy, linearity, robustness, LOD, and LOQ, and all parameters were found within acceptable limits. he developed RP-HPLC procedure was successfully utilized for analysis of marketed tablet formulation and was found suitable for routine quality control and stability studies of Ritonavir and Lopinavir.

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{203548,
        author = {Anjali Suryakant Gore and Dr. N. G. Patre and Dr. Sayyed Javvad Ali},
        title = {Development And Validation Of Stability-Indicating RP-HPLC Method For Simultaneous Estimation Of Ritonavir And Lopinavir In Tablet Dosage Form},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {11558-11572},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=203548},
        abstract = {A simple, accurate, precise, and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Ritonavir and Lopinavir in bulk drug and pharmaceutical tablet dosage forms. Chromatographic separation was performed using an XTerra C18 column with a mobile phase consisting of 0.1% orthophosphoric acid buffer (pH 2.8) and methanol (45:55 v/v) at a flow rate of 1.0 mL/min, with detection at 229 nm. The developed method shows good chromatographic separation with satisfactory retention time, peak symmetry, and system suitability parameters. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the stability-indicating capability of the method. Maximum degradation was observed under alkaline conditions. The method was validated according to ICH guidelines for specificity, precision, accuracy, linearity, robustness, LOD, and LOQ, and all parameters were found within acceptable limits. he developed RP-HPLC procedure was successfully utilized for analysis of marketed tablet formulation and was found suitable for routine quality control and stability studies of Ritonavir and Lopinavir.},
        keywords = {Ritonavir; Lopinavir; RP-HPLC; Stability-indicating method; Method validation; Forced degradation studies; ICH guidelines; Antiretroviral drugs; Pharmaceutical analysis; Chromatographic method development.},
        month = {May},
        }

Cite This Article

Gore, A. S., & Patre, D. N. G., & Ali, D. S. J. (2026). Development And Validation Of Stability-Indicating RP-HPLC Method For Simultaneous Estimation Of Ritonavir And Lopinavir In Tablet Dosage Form. International Journal of Innovative Research in Technology (IJIRT), 12(12), 11558–11572.

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