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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Quality by design (QBD) approach to develop RPHPLC method for determination of diltiazem hydrochloride

Author: SANDHYA JAISWAL, G.D.GUPTA
Abstract: This study presents the application of quality by design (QbD) approach to develop precise, accurate and sensitive RP-HPLC method for determination of Diltiazem (DTZ) in nano drug delivery systems. The main objective of the study was to define “Design Space” a region that guarantees the robustness of method performance. As an initial step, the analytical target profile (ATP) was defined and critical quality attributes (CQAs) were identified. Factor screening studies were performed using Taguchi design, to identify the critical process parameter. Mobile phase ratio, flow rate and buffer pH were identified as critical process parameters (CPM). Optimization of RP HPLC method was performed using Box-Behnken design using CPM. The optimal chromatographic separation employ “Phenomex C18” (4.6x250mm), mobile phase acetonitrile: triethylamine buffer (pH 3.0) in a ratio 47:53, delivered at flow rate 0.6 ml/min and oven temperature at 400C. Diltiazem was detected at 240 nm. The method was validated as per ICH guidlines Q2A and Q2B and indicated higher linearity, accuracy; precision and robustness of method within define “Design Space”.
Keyword: Quality by design, Diltiazem, Design Space, Taguchi, Box-Behnken, Validation, ICH.
DOI: https://doi.org/10.31838/ijpr/2019.11.04.203
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