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Development and validation of novel UV spectrophotometric and RP-HPLC method for the estimation of paroxetine hydrochloride in bulk and pharmaceutical dosage forms | Abstract
Scholars Research Library

Scholars Research Library

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Abstract

Development and validation of novel UV spectrophotometric and RP-HPLC method for the estimation of paroxetine hydrochloride in bulk and pharmaceutical dosage forms

Author(s): B. Praveen Kumar, S. Vidyadhara, T. E. G. K. Murthy, J. Ramesh Babu and R. L. C. Sasidhar

The present paper illustrates about development and validation of a new, simple, precise and accurate Spectrophotometric and RP-HPLC method with enhanced sensitivity for the determination of the antidepressant paroxetine (PXT) in bulk and its dosage forms. The drug showed good absorbance in water at 294 nm, hence water is selected as a solvent and validation is performed. Under the optimized conditions, linear relationship with good correlation coefficient (0.9993) was found between the concentration range of 10-50 μg/ml. The limits of detection and quantitation for the method were 0.3 and 0.9 μg/ml, respectively. The precision of the method was satisfactory; the values of relative standard deviations did not exceed 2%. The recovery values were 100.2 ± 1.61%. The chromatographic method was developed on AGILENT HPLC with UV detection. The method was optimized by Kromosil-C18, (250 * 4.6mm, 5μ) column by using Phosphate buffer (pH_ 6): Acetonitrile (60:40) as a mobile phase with 1 ml/min as flow rate. The detection wavelength is 294 nm. The optimized method was validated with good correlation coefficient (0.9999) was found between the concentration range of 20-100 μg/ml. The limits of detection and quantitation for the method were 0.7 and 2.4 μg/ml, respectively. The precision of the method was satisfactory; the values of relative standard deviations did not exceed 2%. The recovery values were 98.6 - 101.85%. The proposed methods are successfully applied for the determination of PXT in bulk and their dosage forms. The method is having higher sensitivity and wider linear range. The proposed method is practical and valuable for its routine application in quality control laboratories for estimation of PXT.


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