ABSTRACT

Efonidipine is a drug used in the treatment of Hypertention. The literature survey did not reveal any stability-indicating method for Efonidipine by high performance thin layer chromatographic technique. Chromatographic separation was optimised for the Efonidipine by using Ethyl acetate: Dichloromethane as a mobile phase in the ratio of 6:1(v/v). The retardation factor was found to be 0.45 ±0.03. Detection wavelength was selected as 250 nm. The linear range for analysis was 500-2500 ng/band which gives good linear relationship with regression coefficient 0.999. The accuracy of the method was determined by the recovery studies. The LOD and LOQ were 73.23 and 221.90 ng/band respectively. Stress degradation conditions like hydrolysis under different pH conditions, photolytic degradation, thermal degradation and oxidative degradation was performed as per ICH Q1A(R2) and Q1B guidelines. This method can conveniently be used for quantitative analysis of Efonidipine on routine basis. Keywords: Efonidipine, Antihypertensive, Stability indicating, HPTLC
Publication date: 01/04/2024

https://ijbpas.com/pdf/2024/April/MS_IJBPAS_2024_7913.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.4.7913