A robust stability indicating HPLC technique for evalution of Pibrentasvir and Glecaprevir in tablet dosage form

  • Patta Salomi Department of Pharmaceutical Analysis, P.Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, India.
  • P. Shobha Rani Department of Pharmaceutical Analysis, P.Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, India.
  • K. Ravindra Reddy Department of Pharmaceutics, P.Rami Reddy Memorial College of Pharmacy, Kadapa. Andhra Pradesh, India.
  • Afreen sultana M.pharm
Keywords: Pibrentasvir, Glecaprevir, HPLC, Cosmicsil, PDA analysis

Abstract

When liver cells gets infected and vandalized, the condition is termed as Hepatitis. HCV therapy is performed with mixture of drugs. For the combined evaluation of Pibrentasvir and Glecaprevir in tablets, a rapid, selective and robust HPLC technique stability indicating was developed herein this work. Analysis was executed by Cosmicsil, with dimensions 250 mm by 4.6 mm column and mobile phase possessing KH2PO4 with 0.1M, 65 ml and 35 ml of methanol and 230 nm of PDA analysis. Elution times were found out as were 1.663 min and 2.249 min, for Pibrentasvir and Glecaprevir respectively with linear ranges 20µg/ml, 60 µg/ml and 50 µg/ml, 150 µg/ml, respectively having detection limits as 0.190 µg/ml and 0.207  µg/ml and quantization limits as 0.634 µg/ml and 0.690 µg/ml. This method is explicit having RSD values as 0.097% Pibrentasir & 0.232% Glecaprevir showing an accuracy of between 98.82 and 100.07% for Pibrentasir 99.31, Glecaprevir 100.45% recovery values. During the investigation of degradation, peaks elution times of degradants greatly varied with the elution times of Glecaprevir and Pibrentasvir thus, proving method‘s power of stability indication and specificity. The validation and degradation stability studies were carried out according to ICH and ICH Q1B Guidelines.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

References

Hepatitis. Medline plus. U. S. National Library of Medicine, accessed on April 2019. Available at: https://medlineplus. gov/hepatitis. html

Colli, A., Berzuini, A., & Prati, D. (2018). Liver se-questration in sickle-cell disease and hepatitis. The Lancet, 392(10164), e16.

Center for Substance Abuse Treatment. (1995). Treatment Improvement Protocol (TIP) Series, No 22.LAAM in the treatment of opiate addiction. Rockville, MD: Department of Health and Human Services.

Gilson R, Brook MG. Hepatitis A, B, and C. Sexually Transmitted Infections, 2006, 82 (Supple 4), iv35-iv39.

Pibrentasavir. Pubchem, U. S. National Library of Medicine. Accessed on April 2019, Available at : https://pubchem. ncbi. nlm. nih. gov/compound/Pibrentasvir

Pibrentasavir. Drug bank. Accessed on April 2019, Available at: https://www. drugbank. ca/drugs/DB13878

Ng, T. I., Krishnan, P., Pilot-Matias, T., Kati, W., Schnell, G., Beyer, J.,.. & Tripathi, R. (2017). In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS5A inhibitor pibren-tasvir. Antimicrobial agents and chemotherapy, 61(5).

Glecaprevir. Pubchem, U. S. National Library of Medicine. Accessed on April 2019, Available at : https://pubchem. ncbi. nlm. nih. gov/compound/Glecaprevir

Glecaprevir. Drug bank. Accessed on April 2019, Available at : https://www. drugbank. ca/drugs/DB13879

Lawitz, E. J., O'Riordan, W. D., Asatryan, A., Freilich, B. L., Box, T. D., Overcash, J. S.,... & Lin, C. W. (2016). Potent antiviral activities of the direct-acting antivirals ABT-493 and ABT-530 with three-day monotherapy for hepatitis C virus genotype 1 infection. Antimicrobial agents and chemotherapy, 60(3), 1546-1555.

Hemalatha, K., Kistayya, C., Nizamuddhin, N. D., & Dastiagiriamma, D. (2018). Simultaneous estima-tion of new analytical method development and validation of glecaprevir and pibrentasvir by high performance liquid chromatography. Innovat In-ternational Journal Of Medical & Pharmaceutical Sciences, 3(7).

Babu, D., Chetty, C. M., & Mastanamma, S. K. (2018). A New Force Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Pibrentasvir and Glecaprevir in Bulk and its Tablet Dosage Form. Pharmaceutical Meth-ods, 9(2).

Sreeram, V., & Venkateswarlu, C. (2018). Stability indicating RP-HPLC method for the simultaneous estimation of glecaprevir and pibrentasvir in drug product. Journal of pharmaceutical sciences and research, 10(11), 2757-2761.

Rama Kumar, K., & Raja, S. (2018). Simultaneous assay of two antiviral agents, Pibrentasvir and Glecaprevir, using stability indicating RP-HPLC method in bulk and tablets. Der Pharmacia Letter, 10(8), 33-47.

Gampa VK, Reddy DS. (2018) RP- HPLC method development and validation for simultaneous es-timation of glecaprevirand pibrentasvir in pharma-ceutical dosage form. Indo american journal of Pharmaceutical sciences, 05 (12), 16827-16840.

Saroja, J., Lakshmi, P. A., Ram Mohan, Y., & Divya, D. (2019). Quantification of antiviral drug combi-nation, Glecaprevir and Pibrentasvir, in bulk and tablet formulation by stability indicating RP-HPLC method. The Pharma Innovation Journal, 8(1), 163-169.

Marakada S, Rao TS, Challa GN. (2018) Develop-ment and validation for the simultaneous estima-tion of glecaprevir and pibrentasavir in drug prod-uct by UPLC. European Journal of Biomedical and Pharmaceutical Sciences, 5 (4), 473-480.

ICH, (2006), Harmonized Tripartite Guideline, Val-idation of Analytical procedure: Text and Method-ology, Geneva, Switzerland.

ICH, (Q1B), (1996), Harmonized Tripartite Guide-line, Stability testing: Photo stability testing of New Drug Substances and Products, in: Proceeding of the International Conference on Harmonization, Geneva.

Published
31-08-2020
How to Cite
Patta, S., P, S. R., K, R. R., & sultana, A. (2020). A robust stability indicating HPLC technique for evalution of Pibrentasvir and Glecaprevir in tablet dosage form. International Journal of Research In Pharmaceutical Chemistry and Analysis, 1(4), 88-94. https://doi.org/10.33974/ijrpca.v1i4.217
Section
Research Article