Analysis of Amantadine Hydrochloride-Phenyl Isothiocyanate Complex in Bulk and Pharmaceutical Dosage Forms by RP HPLC-PDA Method.

ABSTRACT

Aim: The aim of the present investigation was to perform the precolumn derivatization of Amantadine Hydrochloride (AMT) with phenylisothiocyanate and to develop a RP-HPLCPDA method for the quantification of Amantadine Hydrochloride-phenylisothiocyanate (AMT-PITC) complex in bulk and dosage forms which is rapid, sensitive and economical. Study Design: Method development and Validation study. Methodology: A Phenomenex C18 RP column of 250 x 4.6mm dimensions and 5μm particle size with mobile phase containing water and acetonitrile (4060% v/v) was used at isocratic mode binary pump and eluent was monitored at 273nm. Results & Discussion: The retention time of AMT-PITC complex was 6.3 min. The developed method showed a good linearity in the concentration range of 10-50μg/mL with a correlation coefficient >0.998. The recoveries ranged between 95-105% with a Relative Standard Deviation of (RSD) < 2%. Conclusion: The developed method was validated as per ICH guidelines and successfully used for quantification of AMT by derivatization with PITC. The method was found to be rapid, specific and accurate.