Spectrophotometric and robust UPLC methods for simultaneous determination of velpatasvir and sofosbuvir in their tablet

Kamal, Amira H.; Mabrouk, Mokhtar M.; Bebawy, Lories I.; Mekky, Mai A

doi:10.1016/j.microc.2019.103996

Cited by 19 publications

(20 citation statements)

References 5 publications

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“…Three spectrophotometric methods (Kamal et al, 2019;Rezk et al, 2019b;Attia et al, 2018) have been reported where SF was determined in the mixture by applying the ratio difference (Kamal et al, 2019;Rezk et al, 2019b), first derivative of ratio spectra method (Kamal et al, 2019;Rezk et al, 2019b), dual wavelength (Rezk et al, 2019b), ratio subtraction (Rezk et al, 2019b), and Savitsky-Golay filters signal processing (Attia et al, 2018). On the other hand, VP has been determined in presence of SF by the first derivative of ratio spectra and ratio difference methods (Kamal et al, 2019) and by direct zero-order spectrophotometric method at 302.5 nm (Rezk et al, 2019b) and 339 nm (Attia et al, 2018). While the reported spectrofluorimetric methods have employed native fluorescence intensity measurements of VP in methanol at 385 nm and 400 nm after excitation at 295 nm (El-Gamal et al, 2018) and in methanol and various surface-active agents at 383 nm after excitation at 339 nm (Omar et al, 2018).…”

Section: Comparison To Other Reported Methodsmentioning

confidence: 99%

“…al. (Rezk et al, 2019b) were able to determine SF in the mixture by applying the ratio difference (Kamal et al, 2019;Rezk et al, 2019b), first derivative of ratio spectra method (Kamal et al, 2019;Rezk et al, 2019b), dual-wavelength (Rezk et al, 2019b) and ratio subtraction (Rezk et al, 2019b). While Attia et.…”

Section: Introductionmentioning

confidence: 99%

“…al (Attia et al, 2018) applied Savitsky-Golay filters signal processing to enable determination of SF in its binary mixture with VP. On the other hand, VP was determined in presence of SF by the first derivative of ratio spectra and ratio difference methods (Kamal et al, 2019) and by direct zero-order spectrophotometric method at 302.5 nm (Rezk et al, 2019b) and 339 nm (Attia et al, 2018). While the reported spectrofluorimetric methods, El-Gamal et.…”

Section: Introductionmentioning

confidence: 99%

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Eco-friendly analytical methods for the determination of compounds with disparate spectral overlapping: application to antiviral formulation of sofosbuvir and velpatasvir

et al. 2021

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Green analytical chemistry is one of the newest trends in analytical chemistry nowadays targeting the concept of green laboratory practices on chemists and environment. In this text, green practices are proposed in this work for the determination of sofosbuvir (SF) and velpatasvir (VP) in their pharmaceutical formulation. The analysis of SF in a binary mixture with VP represents an analytical challenge due to the complete overlapping of the UV spectrum of SF by that of VP. Therefore, the direct absorbance and derivative measurements cannot resolve such interference and failed to determine SF. In this paper, three direct and simple methods were developed for the analysis of SF without any interference from VP without sample pre-treatment. The proposed methods include measuring the second derivative amplitude of the ratio spectrum of the mixture using VP as a divisor, measuring the absorbance difference of the mixture in NaOH solution against its HCl solution, and using the derivative compensation technique. On the other hand, VP was determined specifically in presence of SF by two methods. Firstly, by its reaction with 4-chloro-7-nitrobenzofurazan (NBD-Cl) where the reaction product was measured spectrophotometrically and spectrofluorometrically and secondly through the reaction of VP with 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH). The calibration curves showed good correlation coefficient (r2 > 0.999). The developed methods were highly precise with RSD% values less than 2%. The method greenness profile was compared with other published methods by applying the eco-scale protocol. Assessment results proved that our analytical procedure is greener than other reported methods. Moreover, upon comparison with other methods, the proposed methods showed better or comparable sensitivity in addition to being inexpensive and ecofriendly. Accordingly, these methods could be readily applied for quality control purposes as an eco-friendly, simple and efficient analytical tool.

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Section: Comparison To Other Reported Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Eco-friendly analytical methods for the determination of compounds with disparate spectral overlapping: application to antiviral formulation of sofosbuvir and velpatasvir

et al. 2021

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“…Specifically it also inhibits HCV viral replication by binding to the two Mg +2 ions present in HCV NS5B polymerases. [2,6,7] VLR is a selective NS-5A inhibitor which binds to domain-I of NS-5A comprising amino acids 33-202 1 . This NS-5A inhibiting component competes with RNA for binding at this site.…”

Section: Original Articlementioning

confidence: 99%

“…The literature review discloses that a very few spectroscopic, [7,8] LC-MS/MS, [9] and high performance liquid chromatographic techniques [10][11][12][13][14][15][16] have been reported for the estimation of VXR, SFR, and VLR. Based on the reported HPLC methods, there is a need to develop a rapid, sensitive reversed-phase-UPLC method for simultaneous estimation of VXR, SFR, and VLR in bulk and formulations.…”

Section: Original Articlementioning

confidence: 99%

Untitled

Maneka¹

2020

AJP

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Aim: The aim of the present research work was to develop a sensitive, rapid and accurate, stability-indicating RP-UPLC method for the simultaneous estimation of voxilaprevir (VXR), sofosbuvir (SFR), and velpatasvir (VLR) in formulations. Materials and Methods: The chromatographic separation of mixture of VXR, SFR, and VLR was attained in isocratic method utilizing a mobile phase of 0.01N potassium dihydrogen orthophosphate (pH 4.8) and methanol in the proportion of 50:50% v/v utilizing a CHS C18 column which has dimensions of 100 × 2.1 mm, 2.0 m particle size and the flow rate of 1.0 mL/min. The detection system was monitored at 260 nm wavelength maximum with 1.0 mL injection volume. Results: The retaining time for VXR, SFR, and VLR was achieved at 1.468 min, 0.606 min, and 0.848 min, respectively. VXR, SFR, and VLR and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity, and precision. Conclusion: The developed method was highly sensitive, rapid, precise, and accurate than the earlier reported methods. The total run time was decreased to 3.0 min; hence, the technique was more precise and economical. Stability studies directed for the suitability of the technique for degradation studies of VXR, SFR, and VLR. The projected method can be utilized for routine analysis in quality control department in pharmaceutical trades.

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A new fluorescence probe for sofosbuvir analysis in dosage form and spiked human plasma

Nasr,

Talaat,

Morshedy

et al. 2024

Luminescence

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A simple, rapid, and low‐cost technique was developed to allow reliable analysis of the anti‐hepatitis C drug sofosbuvir in bulk, tablet form, and spiked human plasma. This method depends on the ability of sofosbuvir to quench the fluorescence of the newly synthesized 2‐amino‐3‐cyano‐4,6‐dimethylpyridine (reagent 3). Elemental analysis and spectral data were used to validate the structure of the synthesized reagent. The newly synthesized reagent exhibited a satisfactory level of fluorescence emission at 365 nm after excitation at 247 nm. All experimental variables that might affect the quenching process were analyzed and optimized. Linearity, range, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ) were all validated in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The concentration range was shown to be linear between 0.1 and 1.5 μg/mL. The technique was effectively utilized for sofosbuvir analysis in both its tablet dosage form and spiked human plasma, with mean percentage recoveries of 100.13 ± 0.35 and 94.26 ± 1.69, respectively.

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Spectrophotometric and robust UPLC methods for simultaneous determination of velpatasvir and sofosbuvir in their tablet

Cited by 19 publications

References 5 publications

Eco-friendly analytical methods for the determination of compounds with disparate spectral overlapping: application to antiviral formulation of sofosbuvir and velpatasvir

Eco-friendly analytical methods for the determination of compounds with disparate spectral overlapping: application to antiviral formulation of sofosbuvir and velpatasvir

Untitled

A new fluorescence probe for sofosbuvir analysis in dosage form and spiked human plasma

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