Abstract

Reversed-phase high-performance liquid chromatographic (HPLC) and thin-layer chromatographic (TLC)—UV densitometric methods were developed for the quality control of lidocaine hydrochloride bulk drug and its injection solutions. The HPLC method used an RP-18 reversed-phase column with methanol—water—1% phosphoric acid—hexylamine (30:70:100:1.4, v/v/v/v) as the mobile phase and detection at 254 nm, with a capacity factor k′ = 0.8. The TLC—UV densitometric method was performed on silica gel plates using diisopropyl ether—acetone—diethylamine (85:10:5, v/v/v) as the developing solvent and UV detection at 254 nm. The response was linear up to 10 μg ml −1 (HPLC) and 8 mg ml −1 (TLC). The RSD of the peak areas was 1.71% for HPLC and 0.55% for TLC, with recoveries in the range 99.6–100.2% for HPLC and 99.2–100.7% for TLC.

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