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

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

  • VENKATA RAVEENDRANATH T Department of Pharmacy, Annamalai University, Tamilnadu, India- 608002

Abstract

Objective: Present work aim 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, 1.8mm) 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. Retention time of BLMX was found to be 0.87min.


Results: 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 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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T, V. R. “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, Sept. 2020, https://innovareacademics.in/journals/index.php/ijpps/article/view/38416.
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