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Quality by design (QBD) approach to develop RPHPLC method for determination of diltiazem hydrochloride
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| Author:
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SANDHYA JAISWAL, G.D.GUPTA
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| Abstract:
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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”.
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| Keyword:
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Quality by design, Diltiazem, Design Space, Taguchi, Box-Behnken, Validation, ICH.
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| EOI:
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| DOI:
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