STABILITY-INDICATING REVERSE-PHASE HIGH- PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND DACLATASVIR IN PURE AND PHARMACEUTICAL FORMULATION
DOI:
https://doi.org/10.22159/ajpcr.2019.v12i18.33961Keywords:
Sofosbuvir,, Daclatasvir,, Reverse-phase high-performance liquid chromatographic,, Stability indicating,, Validation,, International Conference on HarmonizationAbstract
Objective: The objective of the study was to develop a novel, simple, sensitive, accurate, precise, and stability-indicating reverse-phase (RP) liquid chromatographic method for simultaneous estimation of sofosbuvir and daclatasvir in pure and pharmaceutical formulation.
Methods: In the present work, chromatographic separation was done using stationary-phase discovery column (250 mm×4.6 mm; 5 μm particle size) and mobile phase consisting of 0.1N potassium dihydrogen orthophosphate buffer:acetonitrile (55:45, v/v), with the flow rate of 1 ml/min, and the detection of column effluents was achieved with photodiode array at 260 nm.
Results: The retention time of sofosbuvir and daclatasvir was found to be 2.32 min and 3.06 min, respectively. Stability-indicating studies were conducted according to the guidelines of International Conference on Harmonization (ICH) Q1A R2, and validation of the method was done as per the ICH guidelines Q2R1. The linearity of the method was in the concentration range of 100–600 μg/ml and 15–90 μg/ml for sofosbuvir and daclatasvir, respectively. The correlation coefficients were found to be 0.9996 and 0.9996 for sofosbuvir and daclatasvir, respectively. The limit of detection and limit of quantification were found to be 0.19 μg/ml and 0.59 μg/ml for sofosbuvir and 0.02 μg/ml and 0.05 μg/ml for daclatasvir, respectively.
Conclusion: The stability-indicating RP high-performance liquid chromatographic (RP-HPLC) method was novel, simple, precise, accurate, and sensitive for simultaneous estimation of sofosbuvir and daclatasvir in pure and pharmaceutical formulations. Hence, the developed method was adopted for qualitative and quantitative analysis of sofosbuvir and daclatasvir in pure and pharmaceutical formulations.
Downloads
References
Phuong HL, Quang VT, Trung QV. A systemic review of hepatitis virus studies: A case of health economic evaluation analysis. Int J Pharm Pharm Sci 2017;9:114-20.
Prasanthi P, Vinitha V, Rambabu G. A review on anti-HCV agents targeting active site and allosteric sites of non-structural protein 5B [NS5B]. Int J Pharm Pharm Sci 2016;8:1-18.
Stedman C. Sofosbuvir, a NS5B polymerase inhibitor in the treatment of hepatitis C: A review of its clinical potential. Therap Adv Gastroenterol 2014;7:131-40.
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368:1867-77.
Santosh VG, Pooja RA. Development and validation of stability indicating UV spectroscopic method for estimation of sofosbuvir. Int J Pharm Biol Sci 2018;8:404-13.
Alavian SM, Rezaee-Zavareh MS. Daclatasvir-based treatment regimens for hepatitis C virus infection: A systematic review and meta-analysis. Hepat Mon 2016;16:e41077.
Stanislas P. Daclatasvir, an efficient inhibitor of the hepatitis C virus replication complex protein NS5A: Review of virological data, treatment rationale and clinical trials. Clin Invest 2013;3:191-207.
Deepa C, Sumalatha R. High performance liquid chromatographic method for the determination of daclatasvir in pharmaceutical dosage forms. Indo Am J Pharm Sci 2017;4:1431-7.
Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015;61:1127-35.
Santosh VG, Pooja RA. Development and validation of stability indicating UV spectroscopic method for estimation of sofosbuvir. Int J Pharm Biol Sci 2018;8:404-13.
Omprakash GB, Vivek GM, Sachin BG, Wale RR, Madhuri VP. Development, validation and stability study of UV Spectrophotometric method for determination of sofosbuvir in bulk and pharmaceutical dosage form. J Pharm Res 2017;11:847-9.
Hassouna ME, Mohamed MA. Novel and facile spectrophotometric techniques for the determination of sofosbuvir and ledipasvir in their tablet dosage form. J Anal Pharm Res 2016;7:92-9.
Jyothi BJ, Padmaja G. UV Spectrophotometric method for estimation of new drug, daclatasvir hydrochloride. Int Res J Pharm 2016;7:1-3.
Khushboo SB, Paresh UP. Development and validation of Q-Absorbance ratio method for simultaneous estimation of sofosbuvir and daclatasvir dihydrochloride in solid dosage form. World J Pharm Pharm Sci 2018;7:730-40.
Chakravarthy VA, Sailaja BB, Praveen KA. Method development and validation of ultraviolet-visible spectroscopic method for the estimation of hepatitis-C drugs daclatasvir and sofosbuvir in active pharmaceutical ingredient form. Asian J Pharm Clin Res 2016;9:61-6.
Amira SE, Shereen MA, Abdalla S, Magda EM. The development of a new validated HPLC and Spectrophotometric methods for the simultaneous determination of daclatasvir and sofosbuvir: Antiviral drugs. J Pharm Pharmacol Res 2017;1:28-42.
Gamal ER, Belal F. Stability indicating 1st derivative synchronous spectrofluorimetric method for determination of newly approved antiviral drug daclatasvir in presence of its oxidative and photolytic degradation products: Application to tablet dosage form. Pharm Anal Acta 2018;9:1-7.
Sandhya RJ, Devanna J. A new RP-HPLC method development and validation for simultaneous estimation of sofosbuvir and velpatasvir in pharmaceutical dosage form. Int J Eng Tech Sci Res 2017;4:145-52.
Rao SN, Rajashekar V, Deeptishalini M. New analytical method development and validation for the simultaneous estimation of velpatasvir and sofosbuvir in pharmaceutical dosage forms. Int J Pharm Ind Res 2018;8:123-8.
Hassouna ME, 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. J Forensic Sci Crim Invest 2017;1:1-11.
Chakravarthy VA, Sailaja BB. 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;3:356-64.
Deepa C, Sumalatha R. High performance liquid chromatographic method for the determination of daclatasvir in pharmaceutical dosage forms. Indo Am J Pharm Sci 2017;4:1431-7.
Hanaa S, Gamal HR, Othman MA. Stability indating HPLC method development and validation for determination of daclatasvir in pure and tablet dosage forms. Indo Am J Pharm Sci 2016;3:1565-72.
Benzil D, Ramachandraiah C, Devanna N. Analytical method development and validation for the simultaneous estimation of sofosbuvir and daclatasvir drug products by RP-HPLC method. Indo Am J Pharm Res 2017;7:480-7.
Magdyatef W, Mostafa SM, Sobhy ME, Elgawish MS. Development and validation of a new, simple-HPLC method for simultaneous determination of sofosbuvir, daclatasvir and ribavirin in tablet dosage form. IOSR J Pharm Biol Sci 2017;12:60-8.
Geetha SA, Rajitha G. Development and validation of stability indicating UPLC method for simultaneous estimation of sofosbuvir and velpatasvir in tablet dosage form. Int J Pharm Sci Res 2018;9:4764-9.
Naser FA, Hemdan A, Maya SE. Development of a robust UPLC method for simultaneous determination of a novel combination of sofosbuvir and daclatasvir in human plasma: Clinical application to therapeutic drug monitoring. Int J Anal Chem 2018;1-9.
Notari S, Tempestilli M, Fabbri G, Libertone R, Antinori A, Ammassari A, et al. UPLC-MS/MS method for the simultaneous quantification of sofosbuvir, sofosbuvir metabolite (GS-331007) and daclatasvir in plasma of HIV/HCV co-infected patients. J Chromatogr B Analyt Technol Biomed Life Sci 2018;1073:183-90.
International Conference on Harmonisation. Guidelines for Validation of Analytical Procedures, Q2 (R1). Geneva: ICH; 2005.
International Conference on Harmonisation. Guideline on Stability Testing of New Drug Substances and Products Text and Methodology, Q1A (R2). Geneva: ICH; 2003.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
