Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Abstract

The ternary mixture under study is a recent hepatitis‐C antiviral medicine composed of three new directly acting antiviral drugs, namely, ombitasvir, paritaprevir, and ritonavir. They are co‐formulated as a single‐dose combined tablet dosage form. With more than 170 million infected patients worldwide, a large production scales of antivirals medicine is expected, and hence, new simple and fast methodologies are required to cover millions of analyses that are done routinely in the different pharmaceutical quality control and research laboratories. Ultraviolet spectrophotometry represents sensitive, fast, and cheap tool of analysis in all research and quality control laboratories that can cover the massive quality control of these regimens. However, the simultaneous determination of these three drugs using multivariate chemometric methods represents a high challenge as their spectra are strongly overlapping besides the large difference in their potency within the same tablet. In this research paper, four new different multivariate chemometric methods were developed for their simultaneous determination, namely, classical least square (CLS), principal component regression (PCR), partial least squares (PLS), and genetic algorithm‐partial least squares (GA‐PLS) techniques. The validated methods do not require extraction, separation, or derivatization steps. A comparative study was conducted among the four developed methods. All methods provided satisfactory results, whereas GA‐PLS showed better analytical performance as it had the lowest error with good higher correlation coefficient. The methods were applied in the simultaneous determination of the three drugs in pure form and in their combined tablet dosage form. The comparison confirmed agreement of the values obtained for all techniques.

Analytical Performance and Greenness Evaluation of Five Multi-Level Design Models Utilized for Impurity Profiling of Favipiravir, a Promising COVID-19 Antiviral Drug

“…Univariate calibration methods could not resolve this severe spectral similarity and overlap. Multivariate models are useful in complex spectral analysis due to the inclusion of many spectral wavelengths instead of a single one, resulting in an improvement in the predictive ability and precision of the models [33]. Thus, five multivariate multi-level chemometric models (CLS, PCR, PLS, GA-PLS, and ANN) were useful in this mixture resolution.…”

Highly sensitive high‐performance thin‐layer chromatography method for the simultaneous determination of molnupiravir, favipiravir, and ritonavir in pure forms and pharmaceutical formulations

“…Being all orally active drugs, their combination is predicted. Although several research articles were reported for determination of FVR in plasma [16][17][18][19][20], or in pharmaceutical dosage forms [7,[21][22][23][24], and also for determination of RTV [10,[25][26][27][28], only two LC-MS/MS methods were reported for MLP determination in human plasma [29,30] and one paper was reported for determination of MLP and FVR simultaneously [31]. Most of such chromatographic techniques, especially those coupled with MS, are expensive and requires highly qualified personnel [32].…”

Simultaneous analysis of two drugs used as supportive treatment for COVID-19: comparative statistical studies and analytical ecological appraisal

“…Although UV-Spectrophotometry is a rapid, sensitive, and inexpensive technique for analysis, it is difficult to apply direct UV-Spectrophotometric techniques to the examination of binary pharmaceutical formulations, owing to spectrum overlap and a lack of specificity. Today, new spectrophotometric techniques that use simple software and math are used to separate overlapping spectra [ 21 ].…”