Simultaneous determination of the brand new two-drug combination for the treatment of hepatitis C: Sofosbuvir/ledipasvir using smart spectrophotometric methods manipulating ratio spectra

Eissa, Maya S.

doi:10.1016/j.saa.2017.04.052

Cited by 26 publications

(7 citation statements)

References 19 publications

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“…The validation parameters are tabulated in Table 18. 32 Table 18 Validation parameters reported by Abdel S et al 25…”

Section: Parameters Resultsmentioning

confidence: 99%

“…The result parameters are tabulated in Table 12. 24 Eissa MS et al 25 developed simultaneous determination of Sofosbuvir and Ledipasvir using smart spectrophotometric methods manipulating ratio method. In this work, various sensitive and selective spectrophotometric methods were first introduced for the simultaneous determination of sofosbuvir and ledipasvir in their binary mixture without preliminary separation.…”

Section: Tablementioning

confidence: 99%

“…The adopted methods were also validated as per ICH guidelines and statistically compared to an inhouse HPLC method. 25 Abo T et al 26 has developed spectrophotometric methods for simultaneous determination of Sofosbuvir and Ledipasvir . These methods were based on direct measurement of ledipasvir at 333nm.…”

Section: Tablementioning

confidence: 99%

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In depth investigation of quantitative analytical and bioanalytical techniques of hepatitic drug sofosbuvir in different matrices: a review

Reema¹,

Dhara²,

Patel³

et al. 2018

JAPLR

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Qualitative and quantitative estimation plays a key role in ensuring the safety and efficacy of drugs in different matrices. A detailed literature survey is one of the most essential requirements for all focused research activities. Sofosbuvir is the drug of choice for Hepatitis C virus infection with a high cure rate. It inhibits RNA polymerase enzyme which is responsible for replication of hepatitis C virus RNA. Sofosbuvir was approved by the U.S. Food and Drug Administration (FDA) in 2013. Sincere effort has been made in the present review to collate all the relevant literature published in various pharmaceutical journals for determination of sofosbuvir in different matrices both individually and in combination with other drugs. The review highlights the basic as well as advanced techniques performed for estimating sofosbuvir. Among different methods, HPLC and UV-Visible spectrophotometry are the most widely used techniques applied by the researchers. Detailed validation parameters are also given for the methods, which helps the researchers to select an analytical technique based on the information sought.

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“…The validation parameters are tabulated in Table 18. 32 Table 18 Validation parameters reported by Abdel S et al 25…”

Section: Parameters Resultsmentioning

confidence: 99%

Section: Tablementioning

confidence: 99%

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In depth investigation of quantitative analytical and bioanalytical techniques of hepatitic drug sofosbuvir in different matrices: a review

Reema¹,

Dhara²,

Patel³

et al. 2018

JAPLR

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“…21 Various HPLC, HPTLC and Spectrophotometric method was reported and for quantitative estimation of Sofosbuvir alone [22][23][24][25][26][27][28][29][30] and in combination with other drugs. [31][32][33][34][35][36][37][38] Various methods were reported for the estimation of Sofosbuvir and DACLA in a combined dosage form. DACLA is official in Indian Pharmacopeia 2018.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation for Simultaneous Estimation of Sofosbuvir and Daclatasvir Dihydrochloride in Pharmaceutical Dosage form by Ratio Derivative and Dual Wavelength Methods

Rathod

Patel

2020

ijpqa

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Development and validation of new simple, sensitive, accurate and precise spectrophotometric method involving ratio derivative and dual-wavelength method, was done as per ICH Q2 (R1) for simultaneous estimation of Sofosbuvir (SOFO) and daclatasvir dihydrochloride (DACLA) in a combined dosage form. The overlapping in the spectra of both drugs was the reason for the selection of both methods. The absorbance difference (ΔA) value between 235.8 nm and 270.6 nm was selected for the quantitative determination of SOFO, where DACLA gives equal absorbance at the selected wavelength in the dual-wavelength method (Method A). The determination of DACLA is done quantitatively by measuring the difference in absorbance value at 249 nm and 268.6 nm where SOFO gives equal absorbance at a selected wavelength. Ratio spectra method (Method B) was based on dividing the spectra of a mixture with standard spectra of one of the analytes, and the first derivative spectra was recorded with Δλ = 8 nm and scaling factor 1. The amount of SOFO and DACLA was estimated in the binary mixtures by computing the first derivative signal at 247.0 nm and 341.0 nm, respectively. The calibration curve was linear in the concentration range of 10–90 μg/mL for SOFO and 4–20 μg/mL for DACLA for both the methods. The methods were successfully applied for the simultaneous determination of these drugs in combined dosage form with acceptable recoveries.

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“…LDP in combination with sofosbuvir is used for the treatment of chronic hepatitis C, genotypes 1-6, usually in combination with other medications depending on the specific genotype [1,2]. A literature review revealed few spectrophotometric, reverse-phase high-performance liquid chromatography (RP-HPLC), stability-indicating RP-HPLC, and UPLC-ESI MS/MS [3][4][5][6][7][8][9][10][11][12][13] methods for the estimation of LDP. The purpose of this work was to develop a simple basic rapid and economic stabilityindicating RP-HPLC method for the determination of LDP in its bulk and pharmaceutical dosage form so as to provide better scope for further research on the drug (Fig.…”

mentioning

confidence: 99%

Development and Validation of Stability-Indicating Reverse-Phase High-Performance Liquid Chromatography Method for the Estimation of Ledipasvir in Bulk and Tablet Dosage Form

Ghante

Sawant

Shinde

et al. 2019

Asian J Pharm Clin Res

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Objective: The objective of this study was to develop a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of ledipasvir (LDP) in bulk and tablet formulation. Methods: Stability-indicating RP-HPLC method was developed and validated for the estimation of LDP in bulk and tablet formulation. RP-HPLC was carried out on HiQ SiL C18 columns (250 mm × 4.6 mm, 5 μ particle size) using mobile phase acetonitrile:1 mM ammonium acetate buffer in the ratio of 90:10 v/v at a flow rate of 1 ml/min. The analytes were monitored using MD 2010 PDA detector at 333 nm. Results: The retention time was found to be 3.843 min. The proposed method was found to be having linearity in the concentration range of 5–30 μg/ml. The number of theoretical plates obtained was 4236.50 which indicate the efficient performance of the column. The limit of detection was 0.305 μg/ml and limit of quantification was 0.923 μg/ml, which indicate the sensitivity of the method; the high percentage recovery indicates that the proposed method is highly accurate. The developed method has been validated according to the ICH guidelines and found to be simple, specific, precise, and accurate. Conclusion: The proposed method is precise, accurate, and stability indicating. Therefore, the proposed method can be used for routine quality control and analysis of LDP during stability studies in bulk samples and tablet dosage forms.

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Simultaneous determination of the brand new two-drug combination for the treatment of hepatitis C: Sofosbuvir/ledipasvir using smart spectrophotometric methods manipulating ratio spectra

Cited by 26 publications

References 19 publications

In depth investigation of quantitative analytical and bioanalytical techniques of hepatitic drug sofosbuvir in different matrices: a review

In depth investigation of quantitative analytical and bioanalytical techniques of hepatitic drug sofosbuvir in different matrices: a review

Development and Validation for Simultaneous Estimation of Sofosbuvir and Daclatasvir Dihydrochloride in Pharmaceutical Dosage form by Ratio Derivative and Dual Wavelength Methods

Development and Validation of Stability-Indicating Reverse-Phase High-Performance Liquid Chromatography Method for the Estimation of Ledipasvir in Bulk and Tablet Dosage Form

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