Analysis of Amantadine Hydrochloride-Phenyl Isothiocyanate Complex in Bulk and Pharmaceutical Dosage Forms by RP HPLC-PDA Method
Sri Kalyani Vemuri
Department of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, India.
N. Ramya Krishna
Department of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, India.
M. J. Mohammad
Department of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, India.
Buchi N. Nalluri *
Department of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, India.
*Author to whom correspondence should be addressed.
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-HPLC-PDA 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 (40:60% 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.
Keywords: Amantadine Hydrochloride, Phenyl isothiocyanate, C18 column, PDA Detection, Method Validation, Derivatization.