STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC

  • Rowthula Prasanna Surya Bhavani Student, School of Pharmaceutical Sciences and Technology,Jawaharlal Nehru Technological University, Kakinada, Andhrapradesh,India
    prasannabhavani2@gmail.com
  • M.Sandhya Maduri Student, School of Pharmaceutical Sciences and Technology, Jawaharlal Nehru Technological University, Kakinada, Andhrapradesh,India

Abstract

A new, simple, precise, accurate, and reproducible RP-HPLC for stability-indicating method development and validation of Ledipasvir and Sofosbuvir in bulk form. Separation ofLedipasvir and Sofosbuvir was successfully achieved Dona Zorbax C8, 250 X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: Methanol (45:55) at a flow rate of 1.0mL/min and the eluate was monitored at 238nm, with a retention time of 3.303 and 7.303minutes for Ledipasvir and Sofosbuvir respectively. The method was validated and their response was found to be linear in the drug concentration range of 45µg/ml to135 µg/ml for Ledipasvirand 200µg/ml to 600 µg/ml for and Sofosbuvir. The values of the correlation coefficient were found to 0.999 for Ledipasvirand 1 for Sofosbuvir respectively. The LOQ for Ledipasvirwere found to be  0.695 respectively. The LOQ for Sofosbuvir was found to be 2.2063 respectively. This method was found to be a good percentage recovery for Ledipasvir and Sofosbuvirwere found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows a good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from the excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity, and Robustness.

Keywords: Ledipasvir, Sofosbuvir, High performance liquid chromatography and UV spectrometry

Downloads

Download data is not yet available.

References

1. Sharma BK. Instrumental methods of chemical analysis, Introduction to Analytical chemistry, 23thed.Goel Publishing House Meerut, 2004, P12-23.

2. Method validation guidelines International Conference on harmonization; GENEVA; 1996.

3. German P, Yang J, West S, Han L, Sajwani K, Mathias A. Effect of food and acid reducing agents on the relative bioavailability and pharmacokinetics of ledipasvir/sofosbuvir fixed dose combination tablet. 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. May 19-21, 2014. Washington, DC. Abstract P_15.

4. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 Apr 11. Epub ahead of print.

5. Jill Denninget al.; Pharmacokinetics, Safety, and Tolerability of GS-9851, a Nucleotide Analog Polymerase Inhibitor for Hepatitis C Virus, following Single Ascending Doses in Healthy Subjects, Antimicrob Agents Chemother. 2013 Mar; 57(3): 1201–1208.

6. Mark Mascoliniet al.; Impact of Food and Antacids on Levels of Ledipasvir and Sofosbuvir, 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy, May 19- 21, 2014, Washington, DC.

7. Gilead Sciences et al.; International non-proprietary name: ledipasvir, sofosbuvir, 2014, Evaluation of Medicines for Human Use.

8. Gilead Sciences et al.; Application for inclusion of ledipasvir/ sofosbuvir (Harvoni®) tablets on the WHO Model List of Essential Medicines,2014.
Statistics
78 Views | 55 Downloads
Citatons
How to Cite
RowthulaPrasanna Surya Bhavani, R. P. S. B., and M. M. M.Sandhya Maduri. “STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC”. World Journal of Current Medical and Pharmaceutical Research, Nov. 2020, pp. 307-18, doi:10.37022/wjcmpr.vi.159.
Section
Research Articles