METHOD DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-VISIBLE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF HEPATITIS-C DRUGS - DACLATASVIR AND SOFOSBUVIR IN ACTIVE PHARMACEUTICAL INGREDIENT FORM

Ashok Chakravarthy V; Sailaja Bbv; Praveen Kumar A

doi:10.22159/ajpcr.2016.v9s3.14616

Authors

Ashok Chakravarthy V Andhra University
Sailaja Bbv
Praveen Kumar A

DOI:

https://doi.org/10.22159/ajpcr.2016.v9s3.14616

Abstract

ABSTRACT
Objective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitative
estimation of hepatitis-C drugs - Daclatasvir and Sofosbuvir in its active pharmaceutical ingredient (API) form.
Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Daclatasvir and Sofosbuvir is
based on measurement of absorption at a wavelength maximum (Î»max) of 317 and 261 nm using methanol as solvent.
Results: The method was validated in terms of specificity, precision, linearity, accuracy, and robustness as per the ICH guidelines. The method was
found to be linear in the range of 50-150% for Daclatasvir and in the range of 43-143% for Sofosbuvir. The percentage recovery values were in the
range of 99.4-100.6% for Daclatasvir and in the range of 99.7-100.6% for Sofosbuvir at different concentration levels. Relative standard deviation for
precision and intermediate precision results were found to be <2%. The correlation coefficient value observed for Daclatasvir and Sofosbuvir drug
substances was not <0.99, 0.99, respectively. Results obtained from the validation experiments prove that the developed method is quantified for the
estimation of Daclatasvir and Sofosbuvir drug substances.
Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis, and also suitable for stability analysis of
Daclatasvir and Sofosbuvir in API form as per the regulatory requirements.
Keywords: Daclatasvir, Sofosbuvir, Method development, Validation, Ultraviolet-visible spectrophotometry.

Downloads

Download data is not yet available.

References

Available from: https://www.en.wikipedia.org/wiki/Daclatasvir.

Assessment Report of Daclatasvir from European Medicines Agency (EMA). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003768/WC500172849.pdf.

Available from: https://www.en.wikipedia.org/wiki/Sofosbuvir.

Product monograph template - Standard from Gilead Sciences. Available from: https://www.google.co.in/?gws_rd=ssl#q=sofosbuvir+product+monograph.

Drug description in RxList. Available from: http://www.rxlist.com/sovaldi-drug.htm.

Information source from drug bank on Sofosbuvir. Available from: http://www.drugbank.ca/drugs/DB08934.

Summary on Compassionate use for Sofosbuvir from EuropeanMedicines Agency (EMA). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/12/WC500156825.pdf.

Sundaram V, Kowdley KV. Dual daclatasvir and sofosbuvir for treatment of genotype 3 chronic hepatitis C virus infection. Expert Rev Gastroenterol Hepatol 2016;10(1):13-20.

Bunchorntavakul C, Reddy KR. Review article: the efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther 2015;42(3):258-72.

Ashok CV, 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(7):356-64.

Shi X, Zhu D, Lou J, Zhu B, Hu AR, Gan D. Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci 2015;1002:353-7.

Debasish S, Gananadhamu S, Shweta B, Bharatam PV, Venkatakrishna A, Barij NS. Characterization of forced degradation products and in silico toxicity prediction of Sofosbuvir: A novel HCV NS5B polymerase inhibitor. J Pharm Biomed Anal 2016;120:352-63.

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. J Chromatogr B Analyt Technol Biomed Life Sci 2016;1008:255-9.

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. J Pharm Biomed Anal 2015;114:97-104.

USP 37, NF 32. United States Pharmacopeial Convention, Rochville, Md, USA; 2014.

European Pharmacopoeia 8.0.

ICH, Q2(R1). Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology in Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use; 2005.

Ashok CV, Sailaja BBV, Praveen KA. Development and validation of a dissolution method for Frovatriptan tablets by reverse phase UPLC. Int J Pharm Pharm Sci 2015;7(4):125-30.

Ravichandran V, Shalini S, Sundramand KM, Rajak H. Validation of analytical methods-strategies and importance. Int J Pharm Pharm Sci 2010;2(3):18-22.

United States Food and Drug Administration. Guidance for Industry: Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. Rockville, MD: Draft Guidance USFDA; 2001.

Validation of Compendial Methods. United States Pharmacopeia 37, National Formulary 32. Ch. 1225. The United States Pharmacopeial Convention, Rockville, MD, USA; 2014.