alexa Abstract | Analytical method development and validation for the estimation of Indinavir by RP-HPLC

Journal of Chemical and Pharmaceutical Research
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Abstract

A simple, rapid, accurate, precise, specific, robust, reproducible reverse phase High Performance Liquid Chromatography method was developed for the estimation of Indinavir in bulk drug and Pharmaceutical dosage form. The quantification was carried out using BDS (250 X 4.6 mm, 5 μ) column with mobile phase comprising 0.1% OPA: acetonitrile in 45:55% v/v at flow rate 1ml/min. Detection was carried out at 258 nm using PDA detector with injection volume 10μl. The retention time was found to be 2.469 minutes. The proposed method was validated as per ICH guidelines. The method produced linear response in the concentration range of 20-100 μg/ml (R2~0.9999). The recovery studies were carried out and found to be within 98.0% - 102.0%. % RSD was found to be below 2%. LOD (Limit of Detection) and LOQ (Limit of Quantification) of Indinavir for this method were found to be 0.24μg/ml and 0.73μg/ml respectively.

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Author(s): T Raj Kumar V Rajeswari and L Sivasanker Reddy

Keywords

Indinavir, acetonitrile, RP-HPLC, Validation, ICH guidelines, Analytical method

 
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