Journal of Pharmaceutical Research

S. Khairnar Nilesh ¹, K. Redasani Vivekkumar ¹, P. Kotkar Rakesh ¹, B. Bari Sanjay ¹, J. Surana Sanjay ¹

Affiliations
1 Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education & Research, Near Karwand Naka, Shirpur – [425 405] Dist-Dhule, IN

Abstract

Two methods, 'UV- Spectrophotometric' and 'First order derivative' methods have been developed for determination of Duloxetine HCl in bulk and in tablets. In Double Reverse osmosis (R.O.) water, Duloxetine HCl showed maximum absorbance at 289 nm and same spectrum was derivatised into first order derivative at Ae = 2; amplitude of the trough was recorded at 275 nm. In both proposed methods Duloxetine HCl follows linearity in the concentration range 10-60 mcg/ml for Simple UV Spectrophotometry&5-30 mcg/ml for first order derivative spectroscopy. Assay results were in good agreement with the label claim. As the percentage relative standard deviations were found to be less than 2, both the methods proved to be precise and accurate.

Keywords

Duloxetine HCl, UV-Spectrophotometry, First Order Derivative.

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K. Redasani Vivekkumar ¹, F. Chhajed Chetan ¹, J. Surana Sanjay ¹

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

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 (R_f 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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