Rapid, accurate and precise method for identification and quantitation of Eperisone Hydrochloride (EPE) was
developed by reversed-phase high performance liquid chromatographic (RP-HPLC) and validated. The solvent system
and wavelength were optimized in order to maximize the sensitivity of the proposed method, Eperisone
Hydrochloride shows the maximum absorbance at 255 nm. The Agilent HPLC 1200 series system, employed with
software EZ Chrom Elite was used for proposed analytical work. Column chromatographic development was carried
out with the help of reversed-phase mode using HiQSil C18 (4.6 mm X 250 mm, 5 mm i.d., 5 μm particle size). The
optimized mobile phase consisted of Methanol: Double distilled water (pH maintain 3) (90:10 %v/v) as the mobile
phase and detection wavelength of 255 nm.Flow rate was kept at 0.8 mL min-1. Drug- Eperisone Hydrochloride was
well resolved and retained at 2.9 min. Performance characteristics of HPLC method for estimation of EPE in bulk and
its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method
validation. This method was validated for accuracy, precision, linearity, LOD & LOQ of sample solution.The HPLC
method was found to be linear with R2 value of 0.9942 and across the range 10 μg/ml- 90 μg/ml. The LOD 0.645
μg/ml and LQD values were found to be 0.645 μg/ml and 1.957μg/ml respectively. The method was found to be
accurate, precise, robust and economical for the analysis of EPE from bulk and its formulation. Thus this method can
be safely and successful employed for analysis of routine samples and quality control of drugs in pharmaceutical
formulations.
Key words: Reversed-phase high performance liquid chromatographic, Eperisone Hydrochloride, Method
Development, Validation, ICH guidelines
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