STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PANOBINOSTAT LACTATEIN PHARMACEUTICAL DOSAGE FORMS BY UPLC

Gorja Ashok; Sumanta Mondal

doi:10.22159/ijpps.2018v10i11.28900

Authors

Gorja Ashok Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Gland Institute of Pharmaceutical Sciences, Kothapet, Medak 502313, Telangana, India,
Sumanta Mondal Department of Pharmaceutical Chemistry, Faculty of Pharmacy, GITAM Institute of Pharmacy GITAM University, Rushikonda, Visakhapatnam 500045, Andhra Pradesh, India

DOI:

https://doi.org/10.22159/ijpps.2018v10i11.28900

Keywords:

Panobinostat lactate, Stability indicating, Method development, Validation, UPLC

Abstract

Objective: The present study aimed to develop a stability indicating ultra-performance liquid chromatography (UPLC) method for the estimation of panobinostat lactate in pharmaceutical dosage form and validate the method in accordance with ICH guidelines.

Methods: The optimized conditions for the developed UPLC method are acquity UPLC hibar C18 (100 mm × 2.1 mm, 1.8µ) column maintained at 30°C with mobile phase consisting of 0.1% ortho phosphoric acid and acetonitrile in the ratio 50:50%v/v on isocratic mode at flow rate 0.3 ml/min. The sample was detected at 266 nm.

Results: The retention time for panobinostat was found to be 1.6 min. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness and solution stability. The method obeyed Beer’s law in the concentration range of 50µg/ml and 300µg/ml with correlation coefficient of 0.9998. Forced degradation studies were conducted by exposing the drug solution to various stress conditions such as acidic, basic, peroxide, neutral, photolytic and thermal conditions. The net degradation was found to be within the limits, indicating that drug is stable in stressed conditions.

Conclusion: The developed method for the estimation ofpanobinostat can be utilized for the routine analysis of pharmaceutical dosage form.

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