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Validated Stability Indicating RP-HPLC Method for Valganciclovir Hydrochloride in its Pure and Pharmaceutical Dosage Form
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| Author:
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SHINDE R, M SUMITHRA
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| Abstract:
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The development and validation of a new stability indicating RP-HPLC method of Valganciclovir hydrochloride
in pure and dosage forms by RP-HPLC was described as per ICH guideline. Drug was studied under isocratic
condition using CHEMSIL C18 (250 X 4.6 mm), 5µm column by used a mobile phase which is isocratic
containing Acetonitrile and 0.05 M ortho phosphate buffer (pH 4.0) is 60:40 v/v ratio was carried out 1.0
ml/min are be the flow rate at ambient column temperature at 254 nm. Degradation study was carried out as
per ICH guidelines in all conditions. Chromatograms of various degradation studies of Valganciclovir
hydrochloride reveals the no degradation was observed and suitability of the developed RP-HPLC method. Study
is going on under force degradation with internal standard. Proposed method was stable and validated as per ICH
guidelines and may helpful for quantification of Valganciclovir HCl in analytical laboratories. Further study was
completed towards their validation and developed method was found to be precise and accurate.
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| Keyword:
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Degradation, HPLC, Method development, Validation.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.207
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| Download:
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