Method Development and Validation for the Determination of Indiquinoline Tartrate, a Novel Kappa Opioid Agonist, and its Related Substances by High-Performance Liquid Chromatography

Abstract

A stability-indicating reversed-phase high-performance liquid chromatography method has been developed and validated for the assay of indiquinoline tartrate and its related substances. The method was established by forced degradation experiments and system suitability experiments. The chromatographic separation was achieved with a Hedera ODS-3 column (5 µm, 250 mm × 4.6 mm) and the mobile phase was constituted (flow rate 1.0 mL/min) of eluant A, aqueous acetate buffer and eluant B, CH(3)OH using a gradient elution. A photodiode array detector set at 254 nm was used for detection. The investigated validation elements showed that the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity with limit of detection and limit of quantitation. The method can be used for routine quality control analysis and stability testing of indiquinoline tartrate drug substance.

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