ArticleBiomedical chromatography : BMC2026
AQbD-Based Development and Optimization of a Stability-Indicating RP-HPLC Method for Imeglimin With Integration of Lean Six Sigma Principles.
Article in Biomedical chromatography : BMC, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
An accurate and green RP-HPLC stability indicating method has been developed for estimation of Imeglimin with an AQbD approach. Method optimization was done based on Box-Behnken design by changing factors like mobile phase, pH, and flow rate for optimum resolution and retention time. Lean Six Sigma (DMAIC) and statistical process control techniques ensured the consistency of the method. Water-methanol in the ratio of 65:35 (v/v) adjusted to pH 4.0 was used as the mobile phase at a flow rate of 0.8 mL/min, having an approximate retention time of 3.7 min. Method validation was performed as per the ICH guidelines, and the method exhibited a high correlation coefficient (R
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