DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UPLC METHOD FOR THE QUANTIFICATION OF BALOXAVIR MARBOXIL IN TABLET FORMULATION

  • T. VENKATA RAVEENDRANATH Department of Pharmacy, Annamalai University, Tamilnadu, India 608002
  • R. T. SARAVANAKUMAR Department of Pharmacy, Annamalai University, Tamilnadu, India 608002
  • C. H. K. V. L. S. N. ANJANA Department of Pharmaceutical Chemistry and Phytochemistry, Nirmala College of Pharmacy, Guntur, Andhra Pradesh 522503

Abstract

Objective: Aim of the present work is to develop a simple, accurate and precise stability-indicating method for the quantification of baloxavir marboxil (BLMX) in tablet dosage form by UPLC.


Methods: Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8 mm) reverse phase column and the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 was processed through a column at a flow rate of 0.3 ml/min. Column oven temperature was maintained at 30 °C and the detection wavelength was processed at 240 nm.


Results: Retention time of BLMX was found to be 0.87 min. Repeatability of the method was determined in the form of %RSD and the value was 0.2. The percentage mean recovery of the method was found to be 99.47%. LOD, LOQ values obtained from the regression equation of BLMX were 0.69 and 2.10 mg/ml, respectively. Regression equation and correlation coefficient values of BLMX were y = 16994x+7179.2 and 0.9996. Drug was subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 5.96% and 9.55%.


Conclusion: Retention time and total run time of the drug was decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of BLMX.

Keywords: Baloxavir marboxil, UPLC, Specificity, Validation, Stability studies

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References

1. Eisfeld AJ, Neumann G, Kawaoka Y. At the centre: influenza a virus ribonucleoproteins. Nat Rev Microbiol 2015;13:28–41.
2. Dias A, Bouvier D, Crepin T. The cap-snatching endonuclease of influenza virus polymerase resides in the PA subunit. Nature 2009;458:914–8.
3. Imai M, Yamashita M, Sakai Tagawa Y. Influenza a variants with reduced susceptibility to baloxavir isolated from Japanese patients are fit and transmit through respiratory droplets. Nat Microbiol 2020;5:27–33.
4. Noshi T, Kitano M, Taniguchi K. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res 2018;160:109–17.
5. ICH: Q2 (R1), Validation of analytical procedures: text and methodology; 2005.
6. ICH: Q2B. Harmonized Tripartite Guideline, Validation of Analytical Procedure: Methodology, IFPMA. In: Proceedings of the International Conference on Harmonization, Geneva; 1996.
7. Swathi P, Vidyadhara S, Sasidhar RLC, Kalyan Chakravarthi K. Method development and validation for the estimation of entecavir in bulk and pharmaceutical dosage forms by RP-HPLC. Int J Curr Pharm Res 2017;9:107-11.
8. Shweta Mishra, Patel CJ, Patel MM. Development and validation of stability indicating chromatographic method for simultaneous estimation of sacubitril and valsartan in pharmaceutical dosage form. Int J Appl Pharm 2017;9:1-8.
9. Prasanthi Chengalva, Latha Lavanya Peddavengari, Madhavi Kuchana. A validated analytical method for the simultaneous estimation of cytarabine and daunorubicin in bulk and infusion formulation by reverse-phase high-performance liquid chromatography. Asian J Pharm Clin Res 2019;12:128-31.
10. Kafiya Suroor, Kudaravalli Sreedevi. RP-HPLC method development and validation for the simultaneous estimation of encorafenib and binimetinib in API and tablet dosage form. Int J Sci Res 2019;8:184-90.
11. Ramesh Guguloth, Madhukar A, Kannappan N, Ravinder A. Method development and validation of new RP-HPLC method for the determination of sofosbuvir tablet. J Pharm Res 2016;5:161-3.
12. Charde MS, Welankiwar AS, Cajole RD. Development of validated RP-HPLC method for the simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form. Int J Adv Pharm 2014;3:1-11.
13. Estella Hermoso de Mendoza A, Imbuluzqueta I. Development and validation of ultra-high performance liquid chromatography-mass spectrometry method for LBH589 in mouse plasma and tissues. J Chromatogr B: Anal Technol Biomed Life Sci 2011;79:3490–6.
14. Kishore Kumar L Mule. Rapid analytical method for assay determination for prochlorperazineedisylate drug substances by Ultra performance liquid chromatography. Int J Curr Pharm Res 2017;9:118-22.
15. Baki Sharon, Meruva Sathish Kumar, Marakatham S, Kanduri Valli Kumari. A New RP-UPLC method development and validation for the simultaneous estimation of ivacaftor and lumacaftor. J Global Trends Pharm Sci 2018;9:5730-7.
16. Madhavi S, Prameela Rani A. Simultaneous reverse phase ultra-performance liquid chromatography method development and validation for estimation of grazoprevir and elbasvir. Asian J Pharm Clin Res 2018;11:100.
17. Ngwa G. Forced degradation studies as an integral part of HPLC stability indicating method development. Drug Delivery Technol 2010;10:56-9.
18. Balaswami B, Ramana PV, Rao BS, Sanjeeva P. A new simple stability indicating RP-HPLC-PDA method for simultaneous estimation of triplicate mixture of sofosbuvir, voxilaprevir and velpatasvir in tablet dosage form. Res J Pharm Technol 2018;11:4147-56.
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RAVEENDRANATH, T. V., R. T. SARAVANAKUMAR, and C. H. K. V. L. S. N. ANJANA. “DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UPLC METHOD FOR THE QUANTIFICATION OF BALOXAVIR MARBOXIL IN TABLET FORMULATION”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 12, no. 11, Nov. 2020, pp. 94-99, doi:10.22159/ijpps.2020v12i11.38416.
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