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Development and Validation of HPTLC/Densitometry Method for the Estimation of Vilazodone HCl in Bulk and in Tablet Formulation


Affiliations
1 Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur - 425405, Dist: Dhule (MS), India
 

A simple, economic, precise, sensitive and accurate HPTLC/densitometry method of analysis for determination of vilazodone HCl in both bulk drug and in tablet formulation was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60 F254 S as the stationary phase. The solvent system consists of toluene:chloroform:methanol (2:2:1). This system was found to give compact spots for vilazodone HCl (Rf value=0.45). Densitometric analysis of vilazodone HCl was carried out in the absorbance mode at 242 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.997 with respect to peak height and peak area, in the concentration range of 200-1200 ng/band. The method was validated as per the ICH guidelines for various parameters like recovery, precision, repeatability and reproducibility. The results obtained proved that the method can be employed for routine analysis of Vilazodone HCl in bulk as well as in tablet formulation. The proposed method also indicates no interference of excipients from tablet formulation.

Keywords

Vilazodone HCl, HPTLC, ICH Guidelines, Validation.
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  • Development and Validation of HPTLC/Densitometry Method for the Estimation of Vilazodone HCl in Bulk and in Tablet Formulation

Abstract Views: 190  |  PDF Views: 78

Authors

K. Redasani Vivekkumar
Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur - 425405, Dist: Dhule (MS), India
F. Chhajed Chetan
Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur - 425405, Dist: Dhule (MS), India
J. Surana Sanjay
Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur - 425405, Dist: Dhule (MS), India

Abstract


A simple, economic, precise, sensitive and accurate HPTLC/densitometry method of analysis for determination of vilazodone HCl in both bulk drug and in tablet formulation was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60 F254 S as the stationary phase. The solvent system consists of toluene:chloroform:methanol (2:2:1). This system was found to give compact spots for vilazodone HCl (Rf value=0.45). Densitometric analysis of vilazodone HCl was carried out in the absorbance mode at 242 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.997 with respect to peak height and peak area, in the concentration range of 200-1200 ng/band. The method was validated as per the ICH guidelines for various parameters like recovery, precision, repeatability and reproducibility. The results obtained proved that the method can be employed for routine analysis of Vilazodone HCl in bulk as well as in tablet formulation. The proposed method also indicates no interference of excipients from tablet formulation.

Keywords


Vilazodone HCl, HPTLC, ICH Guidelines, Validation.