DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF EPERISONE HYDROCHLORIDE IN BULK DRUG
Keywords:
Validation, Eperisone hydrochloride, HPTLC, ChromatographyAbstract
Objective: A new, economical, precise and accurate stability indicating HPTLC method was developed and validated for the determination of Eperisone hydrochloride in bulk drug.
Methods: Sample and standard solutions of Eperisone hydrochloride was applied on precoated silica gel G 60 F254 HPTLC plate and the plate was developed using Toluene: Chloroform: Ethanol (4:4:1v/v/v) as mobile phase. The detection was performed at 266 nm
Results: The calibration curve was found to be linear between 100 to 700 ng/spot for Eperisone hydrochloride with correlation coefficients 0.999. The Rf value for Eperisone hydrochloride was found to be 0.26±0.03. The LOD and LOQ were found to be 100 ng/spot and 300 ng/spot for Eperisone hydrochloride. The selected drug was subjected to acid, alkali and oxidative degradation and study revealed, Eperisone hydrochloride is well resolved from pure form with significant differences in their Rf this method can be successfully employed for quantitative analysis of Eperisone hydrochloride in bulk drug.
Conclusion: The proposed method has been validated as per ICH Q2 (R1) guidelines. This method can be used for routine quality control analysis of Eperisone hydrochloride in bulk drug.
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References
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