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A Review on Method Development and Validation using HPLC


Adhikari, R., Singh, B.K.

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High performance liquid chromatography (HPLC) is an analytical technique which is used to separate, detect and quantify various drugs and its related degradants. It is employed to separate manufactured drugs from drug related impurities, to detect and quantify synthesized drug and to reduce other impurities at the time of separation. 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. Validation of HPLC as per ICH guidelines covers all the performance characteristics of validation, likeaccuracy, precision, specificity, linearity, range, limit of detection, limit of quantification, robustness and system suitability testing.


HPLC, Validation, Method Development, Degradants

Cite This Article

Adhikari, R., Singh, B.K. (2016). A Review on Method Development and Validation using HPLC, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(3), 167-172.

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