Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PHARMACEUTICAL DRUGS BY RP-HPLC METHOD

Sen Shailesh*, Sharma Ranu, Kachawa Vijay Singh, Garg Ayush and Dwivedi Dr. Jayesh

ABSTRACT

Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable reverse phase HPLC method was developed for the separation and estimation of two drugs hydrochlorothiazide and eprosartanin bulk drug mix and pharmaceutical dosage forms. The estimation was carried out using column; mobile phase consisting of methanol, orthophosphoric acid and buffer at pH 5; the flow rate of 1.7 mL/min and ultraviolet detection at 232 nm. All the drugs were properly resolved having run time of 2.5 and 4.3 minutes for hydrochlorothiazide and eprosartan, respectively. The method was validated as a final verification of method development with respect to precision, linearity, accuracy, ruggedness, and robustness. The validated method was successfully applied to the commercially available pharmaceutical dosage form, yielding very good and reproducible result.

Keywords: RP-HPLC, hydrochlorothiazide and eprosartan, method development.


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