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Dr. Muhammad Baqir MR Fakhrildin
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Miss. Harshitaben Patel*, Prof. Vishwas Bhagat and Dr. Rajkumar Shete


HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. Many different strategies of high performance liquid chromatographic method development are used today. HPLC is an analytical tool which can detect, separate and quantify the drug, its various impurities and drug related degradants that can form on synthesis or storage. It involves the understanding of chemistry of drug substance and facilitates the development of analytical method. Most of the drugs in multi component dosage forms can be analyzed by HPLC method because of the several advantages like rapidity, specificity, accuracy, precision and ease of automation in this method. A number of chromatographic parameters were evaluated in order to optimize the method. An appropriate mobile phase, column, column temperature, wavelength and gradient must be found that affords suitable compatibility and stability of drug as well as degradants and impurities.

Keywords: High Pressure Liquid Chromatography (HPLC), Method validation, Method development.

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