Stability indicating validated UPLC method for determination of Nebivolol HCl in bulk and pharmaceutical dosage form

Kamepalli Sujana, P. Jagadish, S. Venu, T. Pavani Priyanka

Research output: Contribution to journalArticle

Abstract

A simple, rapid, precise and accurate stability indicating ultra-performance liquid chromatography method was developed and validated for the quantitative determination of Nebivolol HCl in bulk drug and Pharmaceutical dosage form. Separation was achieved on a Ethylene Bridge Hybrid C18 (2.1 x 50mm, 1.7 μm) column with auto injection system at a detection wavelength of 281nm, using a mobile phase consists of potassium di hydrogen phosphate (25%) and Acetonitrile (75%) in a isocratic elution mode at a flow rate of 0.25mL per min. The detection wavelength of 281 nm for Nebivolol HCl with an injection volume of 5.0μL. The retention time for Nebivolol HCl was found to be 0.5mL per min. The developed UPLC method was validated for selectivity, linearity, accuracy, robustness, precision and specificity as per ICH guidelines. The method also carried for forced degradation studies. The linearity range was found to be 10-50μg/mL for Nebivolol HCl with a correlation coefficient of 0.999. Limit of quantification and Limit of detection was found to be 9.97 and 2.95μV.The method is Precise and Robust and indicated by %RSD. The results were indicating that the method was selective in analysis of Nebivolol HCl in the presence of degradation products under various stress conditions.

Original languageEnglish
Pages (from-to)533-537
Number of pages5
JournalResearch Journal of Pharmacy and Technology
Volume9
Issue number5
DOIs
Publication statusPublished - 01-01-2016

Fingerprint

Nebivolol
Dosage Forms
Pharmaceutical Preparations
Injections
Liquid Chromatography
Limit of Detection
Hydrogen
Potassium
Phosphates
Guidelines

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Pharmacology (medical)

Cite this

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abstract = "A simple, rapid, precise and accurate stability indicating ultra-performance liquid chromatography method was developed and validated for the quantitative determination of Nebivolol HCl in bulk drug and Pharmaceutical dosage form. Separation was achieved on a Ethylene Bridge Hybrid C18 (2.1 x 50mm, 1.7 μm) column with auto injection system at a detection wavelength of 281nm, using a mobile phase consists of potassium di hydrogen phosphate (25{\%}) and Acetonitrile (75{\%}) in a isocratic elution mode at a flow rate of 0.25mL per min. The detection wavelength of 281 nm for Nebivolol HCl with an injection volume of 5.0μL. The retention time for Nebivolol HCl was found to be 0.5mL per min. The developed UPLC method was validated for selectivity, linearity, accuracy, robustness, precision and specificity as per ICH guidelines. The method also carried for forced degradation studies. The linearity range was found to be 10-50μg/mL for Nebivolol HCl with a correlation coefficient of 0.999. Limit of quantification and Limit of detection was found to be 9.97 and 2.95μV.The method is Precise and Robust and indicated by {\%}RSD. The results were indicating that the method was selective in analysis of Nebivolol HCl in the presence of degradation products under various stress conditions.",
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Stability indicating validated UPLC method for determination of Nebivolol HCl in bulk and pharmaceutical dosage form. / Sujana, Kamepalli; Jagadish, P.; Venu, S.; Priyanka, T. Pavani.

In: Research Journal of Pharmacy and Technology, Vol. 9, No. 5, 01.01.2016, p. 533-537.

Research output: Contribution to journalArticle

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