Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic study

Pan, Chen‐Wei; Chen, Yongping; Chen, Weilai; Zhou, Guangyao; Liu, Jin; Zheng, Yi; Lin, Wang; Pan, Zhenzhen

doi:10.1016/j.jchromb.2015.11.056

Cited by 87 publications

(47 citation statements)

References 21 publications

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“…Sofobuvir was found to be stable as long term shock at-28±5 °C (37 d) and-80 °C (37 d). When compared to previous bio-analytical methods [6][7][8], the developed method was simple, economical and accurate bio-HPLC method in human plasma. …”

Section: Long Term Shock Stock Solution Stability Studiesmentioning

confidence: 99%

“…The literature survey revealed that very few analytical methods reported for estimation of sofosbuvir, in single and combination, RP-HPLC [3][4][5], bio-analytical UPLC-ESI-MS/MS method [6], in rat plasma by UPLC-MS/MS for quantification of sofosbuvir and its metabolites [7], UHPLC-MS/MS method [8]. The primary goal of this work was to produce a simple, sensitive, specific and economic bioanalytical RP-HPLC-PDA detection method for the determination of sofosbuvir from human plasma that is applicable in further pharmacokinetics studies.…”

Section: Introductionmentioning

confidence: 99%

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Bioanalytical Method Development and Validation for the Determination of Sofosbuvir From Human Plasma

Madhavi

Rani

2017

Int J Pharm Pharm Sci

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Objective: This study points to build up and validate a simple methodology to quantify the most used drug sofosbuvir for the treatment of hepatitis C virus (HCV) infection, in human plasma by using atazanavir as an Internal Standard (IS) for preclinical studies and validate as per USFDA guidelines.Methods: Sofosbuvir was isolated from plasma samples by liquid-liquid extraction method using acetonitrile; good chromatographic separation was achieved on Kromasil Column (250 mm ×4.6 mm, 5 µm). The mobile phase consisted of 0.1 % orthophosphoric acid (OPA) buffer pH 2 and acetonitrile in the ratio of (68:32, v/v), respectively. The analysis time was 7 min at a flow rate 1 ml/min. The photodiode array detector (PDA) detection was carried out at 228 nm. The suggested method was validated by performing linearity, system suitability, specificity and sensitivity, accuracy and precision, recovery, ruggedness, stability studies. The method was validated as per USFDA guidelines. Results:The developed method resulted in retention times of sofosbuvir and IS were found out to be 4.7 and 4.2 min respectively. The calibration curves are linear (r2 = 0.999) over the concentration range of 0.050-2.0 µg/ml of plasma analytes concentration. LOQ value was found to be 0.050 µg/ml with precision and accuracy. Within-batch % mean accuracy of the method ranged between 96.00% and 109.09%, and within-batch and total precision, expressed as the coefficient of variation, was 1.40-10.33%. Overall percentage mean recovery of sofosbuvir from spiked plasma was 84.14%. All the validated parameters were found to be within the limit. Conclusion:A simple, accurate, precise, linear, rugged and rapid RP-HPLC method was developed for quantitative estimation of sofosbuvir in human plasma and should be suitable for conducting pharmacokinetics studies and therapeutic drug monitoring.

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Section: Long Term Shock Stock Solution Stability Studiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Bioanalytical Method Development and Validation for the Determination of Sofosbuvir From Human Plasma

Madhavi

Rani

2017

Int J Pharm Pharm Sci

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“…LDV chemical name is methyl Different published articles were concerned with the detection of LDV including spectrophotometry, [19] reversed phase high performance liquid chromatography, [12,20] Ultra performance liquid chromatography coupled with mass spectrometry. [21] Although, the selected drugs were detected using different chromatographic techniques, the introduction of new CZE method faced many advantages, such as minimizing solvent consuming, cost benefit technique and high separation speed. The point of view in this article is the suggestion of a new CZE approach to separate and detect SOF and LDV in their pure forms and combined tablets.…”

Section: -(24-dioxo-34-dihydro-1(2h)-pyrimidinyl)-4-fluro-3-hydroxmentioning

confidence: 99%

Validated Capillary Zone Electrophoresis Approach for Simultaneous Separation and Determination of Hepatitis C Sofosbuvir and Ledipasvir in Tablet Dosage Form

El‐Tohamy¹

2017

WJPR

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Our strategy in this study concerned with the development of a simple, highly sensitive and precise capillary zone electrophoresis method for the simultaneous separation and quantification of hepatitis C drugs sofosbuvir and ledipasvir in pure forms and their combined tablets. respectively. Excellent quantification/detection ratios of 5/1.5 and 20/6.0 μg mL -1 were obtained for sofosbuvir and ledipasvir, respectively. The method was validated to ensure its suitability using ICH guidelines.

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“…All the performed methods used the ultraperformance liquid chromatography -tandem mass spectroscopy (UPLC-MS/MS) technique for the studied drug determination with other antiviral drugs like ribavirin, ledipasvir or with its metabolite [5][6][7].…”

Section: Sofosbuvir (Sfv) (Isopropyl (2s)-2-[[[(2r3r4r5r)-5-(2mentioning

confidence: 99%

Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms

Abdel-Gawad¹

2016

Eur. J. Chem.

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Two methods, a reversed phase high-performance liquid chromatographic (RP-HPLC) method and a direct ultra-violet spectrophotometric method, were adopted and validated for the quantification of sofosbuvir, which is a new antiviral agent used for treatment of patients with hepatitis C virus (HCV). Validation parameters such as linearity, accuracy, precision, specificity, limits of detection and quantification were determined according to the guidelines of International Conference on Harmonization (ICH)-Q2B. The RP-HPLC method was applied on Hypersil TM ODS C18 column (150×4.6 mm, 5 µm) as a stationary phase. The mobile phase was optimized according to the polarity of the studied drug. It was methanol: acetonitrile (90:10, v:v), pumped using an isocratic mode with flow rate of 1 mL/min and UV detection at 260 nm. The UV spectrophotometric method was performed for the studied drug at 260 nm. The calibration curves were linear in the ranges of 2-60 µg/mL and 5-40 µg/mL for the RP-HPLC and UV spectrophotometric methods, respectively. The proposed methods are accurate, sensitive and precise, so they can be successfully adopted for the reliable determination of sofosbuvir content in its tablet form.

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Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic study

Cited by 87 publications

References 21 publications

Bioanalytical Method Development and Validation for the Determination of Sofosbuvir From Human Plasma

Bioanalytical Method Development and Validation for the Determination of Sofosbuvir From Human Plasma

Validated Capillary Zone Electrophoresis Approach for Simultaneous Separation and Determination of Hepatitis C Sofosbuvir and Ledipasvir in Tablet Dosage Form

Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms

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