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Development and Validation of Bendmustine Hydrochloride for Injection and Studies of Degradation By Using Reverse Phase Liquid chromatography
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| Author:
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SRIDHAR J.V.S, LAVKUMAR UPALLA, ANDREWS B. S. A, V.D.N. KUMAR ABBARAJU, NAGARAJU DASARI
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| Abstract:
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A validated HPLC method was developed for the determination of Bendmustine(BND) Hydrochloride (BND) in
pharmaceutical formulation. Isocratic elution at a flow rate of 1.0 ml/min was employed on Symmetry shield RP18,
250mm x 4.6mm, 5µm or Equivalent. A mixture Buffer : Acetonitrile 58:42v/v were prepared and used as mobile
phase. The UV detection wavelength was 233nm and 20µl sample was injected. The run time is About 15 minutes
for Sample, Unmarked, Placebo, System suitability, Sensitivity solution and 60minutes for diluted Regular. The
Approximate retention time was founded for BND is ± 2.4 minutes. The% R.S.D BND was identified. The mean
Percentage recovery for Gemcitabine is found within the specification limit. The method was validated as per the
ICH guidelines. Thus, the proposed HPLC method can be successfully applied for the routine quality control
analysis of formulations. The method developed is simple and is better than the methods reported in the literature.
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| Keyword:
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RP-HPLC Refractive index detector, BND, flow rate, column, ICH Guidelines, USP reference.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2019.11.04.084
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| Download:
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