QUANTITATIVE ESTIMATION OF MIDODRINE HYDROCHLORIDE BY RP-HPLC AND UV-SPECTROPHOTOMETRY METHODS

Four methods RP–HPLC and UV–Spectrophotometry (Zero Order – AUC, First Order Derivative using Amplitude and First Order Derivative using AUC) have been developed for determination of Midodrine Hydrochloride in bulk and tablets. RP – HPLC method are found to be accurate, precise, rugged and sensitive. A simple, sensitive, precise and accurate RP – HPLC method for the determination of Midodrine Hydrochloride both bulk and pharmaceutical formulation has been developed and validated as per the International Conference on Harmonization (ICH) guidelines. The % RSD value for intra – day and inter – day precision was found to be in the range of 0.45 – 1.37 % and 1.48 – 1.55 %. The mean % recovery was found to be in the range of 98.87 – 99.59 %. The low values of LOD (0.09 µg) and LOQ (0.28 µg) indicate high sensitivity of the method. The developed method can routinely be used for analysis of Midodrine Hydrochloride in pharmaceutical formulations. Three simple, rapid, accurate, precise, reliable and economical UV – Spectrophotometry methods have been proposed for the determination of Midodrine Hydrochloride in bulk and in pharmaceutical formulation. Method 2 is zero order UV – Spectrophotometry using Area Under Curve Method, Method 3 is first order derivative UV – Spectrophotometry using Amplitude and Method 4 first order derivative UV – Spectrophotometry using Area Under Curve Method. The developed methods have shown good results in terms of linearity, accuracy, precision and sensitivity for bulk drug and marketed formulation as well.

Key words: Midodrine hydrochloride, HPLC, UV-Spectrophotometry, Method Development, validation