DEVELOPMENT AND VALIDATION OF TLC-DENSITOMETRIC METHOD FOR ESTIMATION OF FLUPIRTINE MALEATE AND ITS FORMULATIONS
AbstractA 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.
Article Information
39
5987-5991
541 KB
333
English
IJPSR
A. Suneetha *, B. Chandra Sekhar and K. Raja Rajeswari
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India.
drasuneetha@gmail.com
30 December 2020
20 April 2021
26 May 2021
10.13040/IJPSR.0975-8232.12(11).5987-91
01 November 2021
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