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<p>The fixed-dose combination of nirmatrelvir and ritonavir is a frontline therapy for coronavirus disease 2019 (COVID-19), with ritonavir acting as a pharmacokinetic enhancer for nirmatrelvir. Reliable analytical methods are essential to ensure the stability, safety, and efficacy of this combination. This study reports the development and validation of a novel instrumental thin-layer chromatography (TLC) method for the simultaneous estimation of nirmatrelvir and ritonavir in bulk and combined dosage forms. Chromatographic separation was achieved using silica gel 60 F<sub>254</sub> TLC plates with a mobile phase of chloroform–methanol (8:2, <i>V/V</i>), and densitometric detection at 235&#xa0;nm. The method was validated in accordance with the International Council for Harmonisation (ICH) Q2(R1) guidelines. It demonstrated excellent linearity in the ranges of 300–1800&#xa0;ng/band for nirmatrelvir and 200–1200&#xa0;ng/band for ritonavir, with correlation coefficients (<i>R</i><sup>2</sup>) above 0.998. Recovery values confirmed high accuracy, while percentage relative standard deviation (%RSD) values for intra- and interday studies confirmed precision. Sensitivity was established with low limit of detection and limit of quantification. Robustness testing confirmed method reliability under varied conditions. The validated TLC method offers a simple, precise, and ecofriendly approach for routine quality control of nirmatrelvir and ritonavir formulations.</p>

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Development and validation of an instrumental thin-layer chromatography method for the simultaneous estimation of nirmatrelvir and ritonavir in combined dosage form

  • 期刊论文

  • 发表日期：

    2026年2月9日

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  • Ronak Makwana,
  • Nikhil K. Mane,
  • Punita Verma,
  • Tejas R. Ghadge,
  • Rushikesh Chandole

摘要

The fixed-dose combination of nirmatrelvir and ritonavir is a frontline therapy for coronavirus disease 2019 (COVID-19), with ritonavir acting as a pharmacokinetic enhancer for nirmatrelvir. Reliable analytical methods are essential to ensure the stability, safety, and efficacy of this combination. This study reports the development and validation of a novel instrumental thin-layer chromatography (TLC) method for the simultaneous estimation of nirmatrelvir and ritonavir in bulk and combined dosage forms. Chromatographic separation was achieved using silica gel 60 F254 TLC plates with a mobile phase of chloroform–methanol (8:2, V/V), and densitometric detection at 235 nm. The method was validated in accordance with the International Council for Harmonisation (ICH) Q2(R1) guidelines. It demonstrated excellent linearity in the ranges of 300–1800 ng/band for nirmatrelvir and 200–1200 ng/band for ritonavir, with correlation coefficients (R2) above 0.998. Recovery values confirmed high accuracy, while percentage relative standard deviation (%RSD) values for intra- and interday studies confirmed precision. Sensitivity was established with low limit of detection and limit of quantification. Robustness testing confirmed method reliability under varied conditions. The validated TLC method offers a simple, precise, and ecofriendly approach for routine quality control of nirmatrelvir and ritonavir formulations.