Maya S. Eissa, Ahmed S. Fayed, Maha A. Hegazy, Ebram B. Kamel
Maya S. Eissa1, Ahmed S. Fayed2, Maha A. Hegazy2, Ebram B. Kamel1*
1Department οf Analytical Chemistry, Faculty οf Pharmacy, Egyptian Russian University, Cairο, Egypt.
2Department οf Analytical Chemistry, Faculty οf Pharmacy, Cairο University, Cairο, Egypt.
Volume - 13,
Issue - 12,
Year - 2020
Daclatasvir and Sofosbuvir are recently co-formulated as antiviral combination for treatment of hepatitis C virus (HCV). Several spectrophotometric methods were developed and validated for determination of the partially overlapped spectra of Daclatasvir and Sofosbuvir with simple data manipulation. Daclatasvir can be directly determined at 316.0 nm with in a linear range of 2.5-25.0 µg/mL. Three approaches were applied for determination of Sofosbuvir; the first is using dual wavelength method at which the absorbance difference between 350.0nm and 270.0nm was recorded and absorption subtraction method where the two drugs have an isosbestic point at 272.0nm. The second approach is derivative spectroscopy using first derivative method, Sofosbuvir can be determined at 253.0nm at which Daclatasvir showed a zero crossing point. The third approach is manipulation of ratio spectra using ratio difference method at which the overlapping spectra of Sofosbuvir divided by a divisor from Daclatasvir where the difference in peak amplitude measured at 257.0nm and 228.0 nm. Ratio derivative method was also applied at which the first derivative corresponding to each ratio spectrum was recorded then the amplitude values were measured at 270.0nm. In these methods Sofosbuvir showed linearity in the range of 10.0-80.0 µg/mL. These methods were validated according to ICH guidelines and was successfully applied to pharmaceutical formulation and showed nonsignificant difference when compared to a well established published method.
Cite this article:
Maya S. Eissa, Ahmed S. Fayed, Maha A. Hegazy, Ebram B. Kamel. Spectrophotometric analysis for simultaneous determination of the new Antiviral drug combination: Daclatasvir/Sofosbuvir in their pure form and Pharmaceutical Preparation. Research J. Pharm. and Tech. 2020; 13(12):5939-5946. doi: 10.5958/0974-360X.2020.01037.9
1. Berenguer M. Systematic review of the treatment of established recurrent hepatitis C with pegylated interferon in combination with ribavirin. Journal of Hepatology. 2008;49(2):274-287.
2. Wang C, Ko H, Yoshida E, Marra C, Richardson K. Interferon‐Based Combination Anti‐Viral Therapy for Hepatitis C Virus After Liver Transplantation: A Review and Quantitative Analysis. American Journal of Transplantation. 2006;6(7):1586-1599.
3. Coilly A, Roche B, Dumortier J, Leroy V, Botta-Fridlund D, Radenne S, et al. Safety and efficacy of protease inhibitors to treat hepatitis C after liver transplantation: a multicenter experience. Journal of Hepatology. 2014;60(1):78-86.
4. Sundaram V, Kowdley KV. Dual daclatasvir and sofosbuvir for treatment of genotype 3 chronic hepatitis C virus infection. Expert review of Gastroenterology and Hepatology. 2016;10(1):13-20.
5. Liao H, Tan P, Zhu Z, Yan X, Huang J. Sofosbuvir in combination with daclatasvir in liver transplant recipients with HCV infection: A systematic review and meta-analysis. Clinics and Research in Hepatology and Gastroenterology. 2017;41(3):262-271.
6. Sumathi K, Thamizhvanan K, Vijayraj S. Development and validation of stability indicating RP-HPLC method for the estimation of daclatasvir in bulk and formulation. Der Pharm Lett. 2016;8(15):107-113.
7. Chakravarthy VA, Sailaja B. Method development and validation of assay and dissolution methods for the estimation of daclatasvir in tablet dosage forms by reverse phase HPLC. Eur J Pharm Med Res. 2016;3(7):356-364.
8. Ariaudo A, Favata F, De Nicolò A, Simiele M, Paglietti L, Boglione L, et al. A UHPLC–MS/MS method for the quantification of direct antiviral agents simeprevir, daclatasvir, ledipasvir, sofosbuvir/GS-331007, dasabuvir, ombitasvir and paritaprevir, together with ritonavir, in human plasma. Journal of Pharmaceutical and Biomedical Analysis. 2016; 125:369-375.
9. Rezk MR, Bendas ER, Basalious EB, Karim IA. Development and validation of sensitive and rapid UPLC–MS/MS method for quantitative determination of daclatasvir in human plasma: Application to a bioequivalence study. Journal of Pharmaceutical and Biomedical Analysis. 2016; 128:61-65.
10. Jiang H, Kandoussi H, Zeng J, Wang J, Demers R, Eley T, et al. Multiplexed LC-MS/MS method for the simultaneous quantitation of three novel hepatitis C antivirals, daclatasvir, asunaprevir, and beclabuvir in human plasma. Journal of Pharmaceutical and Biomedical Analysis. 2015; 107:409-418.
11. Nannetti G, Messa L, Celegato M, Pagni S, Basso M, Parisi SG, et al. Development and validation of a simple and robust HPLC method with UV detection for quantification of the hepatitis C virus inhibitor daclatasvir in human plasma. Journal of Pharmaceutical and Biomedical Analysis. 2017; 134:275-281.
12. Srinivasu G, Kumar KN, Thirupathi C, Narayana CL, Murthy CP. Development and validation of the chiral HPLC method for daclatasvir in gradient elution mode on amylose-based immobilized chiral stationary phase. Chromatographia. 2016; 79(21-22): 1457-1467.
13. Azab SM, Fekry AM. Electrochemical design of a new nanosensor based on cobalt nanoparticles, chitosan and MWCNT for the determination of daclatasvir: a hepatitis C antiviral drug. RSC Advances. 2017;7(2):1118-1126.
14. Hassouna ME-KM, Abdelrahman MM, Mohamed MA. Assay and Dissolution Methods development and validation for simultaneous determination of Sofosbuvir and Ledipasvir by RP-HPLC method in tablet dosage forms. Journal of Forensic Science and Criminal Investigations. 2017;1(3):555-562.
15. Elkady EF, Aboelwafa AA. A rapid and optimized LC-MS/MS method for the simultaneous extraction and determination of sofosbuvir and ledipasvir in human plasma. Journal of AOAC International. 2016;99(5):1252-1259.
16. Rezk MR, Basalious EB, Karim IA. Development of a sensitive UPLC-ESI-MS/MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: application to a bioequivalence study. Journal of Pharmaceutical and Biomedical Analysis. 2015; 114:97-104.
17. Topagi KS, Jeswani RM, Sinha PK, Damle MC. A validated normal phase HPLC method for simultaneous determination of drotaverine hydrochloride and omeprazole in pharmaceutical formulation. Asian Journal of Pharmaceutical and Clinical Research. 2010;3(1):20-24.
18. Pan C, Chen Y, Chen W, Zhou G, Jin L, Zheng Y, et al. Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic study. Journal of Chromatography B. 2016; 1008:255-259.
19. Rezk MR, Bendas ER, Basalious EB, Karim IA. Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies. Journal of Chromatography B. 2016; 1028:63-70.
20. Abdelwahab NS, Farid NF. Innovative spectrophotometric methods for determination of newly discovered combination for hepatitis C treatment. Analytical Chemistry Letters. 2016; 6(6): 783-794.
21. Salinas F, Nevado JB, Mansilla AE. A new spectrophotometric method for quantitative multicomponent analysis resolution of mixtures of salicylic and salicyluric acids. Talanta. 1990; 37(3): 347-351.
22. Abdelwahab NS, El-Zeiny BA, Tohamy SI. Two spectrophotometric methods for simultaneous determination of some antihyperlipidemic drugs. Journal of Pharmaceutical Analysis. 2012;2(4):279-284.
23. ICH, Q2 (R1) validation of analytical procedures: text and methodology, Proceeding of The International Conference on Harmonization, Geneva, 2005.
24. Saleh H,Ragab GH, Othman AM. Stability Indicating HPLC Method Development and validation for determination of daclatasvir in pure and tablets dosage forms. INDO American Journal of Pharmaceutical Sciences. 2016;3(12):1565-1572.