A Validated RP-HPLC Method for the Determination of Bendamustine Hydrochloride in Tablet Dosage Form Using Gemcitabine Hydrochloride as Internal Standard

Authors: Kiran Kumar KATARE, Venkata Nadh RATNAKARAM, Nagoji K.E.V.

Using gemcitabine hydrochloride as an internal standard, an accurate, sensitive, precise and robust reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of bendamustine in bulk and dosage forms. The proposed method was validated as per the ICH guidelines (2005) and can be applied for the quantitative analysis of bendamustine in bulk and pharmaceutical dosage forms. The chromatographic separation was performed on ODS C-18 RP column (4.6 mm i.d x 250 mm) at ambient temperature using a mixture of methanol : water (50:50 v/v) as a mobile phase and at a flow rate of 1.0 ml/ min, while UV detection was performed at 232 nm. The retention times of gemcitabine and bendamustine were in the ranges of 6.647–6.797 and 11.66–12.49 minutes, respectively. The method was found to be linear in the range of 1 – 10 μg/ml. The LOD and LOQ for bendamustine were found to be 0.0422 and 0.1279 µg/ml respectively. Analytical recovery varied from 98.9% to 99.13%. The percentage RSD for precision and accuracy of the method was found to be less than 2%.

Comments: 8 Pages. OK

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[v1] 2019-05-19 05:26:34

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