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A stability indicating isocratic reversed phase hplc-uv method for assay determination of levo bupivacaine base

Author: 
Kamlesh Patel, Dr. Ashaben Patel, Upendra Patel and Pradhuman Parmar
Subject Area: 
Health Sciences
Abstract: 

A isocratic reversed phase high performance liquid chromatography method was developed for the assay of levo bupivacaine base in bulk and dosage forms. The HPLC method was validated as per ICH guidelines. The chromatographic separation was achieved on a Hypersil BDS C18, 250×4.6mm,5µm column, mobile phase mix buffer using analytical grade K2HPO4, K2HPO4, KOH and acetonitrile in 1000 ml, isocratic flow rate 1.0 mL/min and system detection is performed at 235 nm has been used for HPLC-UV. Levo bupivacaine base in synthesis process and formulation. The method determination limit of specification of are the correlation coefficient was 0.999, accuracy, precision and the limits of detection and quantification found to be linear in the range of 1 µg/mL to with 300 µg/mL, recovery of assay levo bupivacaine base (99%-101%) also analyzed on newly developed HPLC method.

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