DEVELOPMENT AND VALIDATION OF TLC-DENSITOMETRIC METHOD FOR ESTIMATION OF FLUPIRTINE MALEATE AND ITS FORMULATIONSAbstract
A simple, precise, accurate, and reliable high-performance thin-layer chromatographic method has been developed and validated for the analysis of flupirtine maleate in capsule dosage form. Identification and analysis were performed on 10 cm × 10 cm layer thickness 0.2 mm, precoated silica gel G60-F254 aluminum sheet, prewashed with methanol, and dried in an oven at 50 °C for 5 min. Ethyl acetate: Chloroform (60 : 40 ) (v/v) was used as mobile phase. A calibration plot was established, showing the dependence of response (peak area) on the amount chromatographed. The validated calibration range was found to be 50-400 ng/spot and for flupirtine maleate with correlation coefficient (r2) 0.999. The average % recovery was between 99.85-100.25%. The limit of detection and limit of quantification for flupirtine maleate were found to be 7.17 and 21.7 ng/spot, respectively. The spots were scanned with a densitometer at λ max 326nm in a reflectance mode. In this method, the drug was achieved Rf value of 0.46±0.02. The proposed method was validated as per ICH guidelines and successfully applied to the estimation of flupirtine maleate in various pharmaceutical dosage forms.
A. Suneetha *, B. Chandra Sekhar and K. Raja Rajeswari
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India.
30 December 2020
20 April 2021
26 May 2021
01 November 2021