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 (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.
ABSTRACT
The aim of the present work was to develop and validate a simple, efficient, economical and LC-MS compatible method for the analysis of Terbutaline sulphate in bulk, dosage forms and in dissolution samples of Terbutaline sulphate tablets by reverse phase high pressure liquid chromatography. A C18 reverse phase column (Phenomenex) of 250 x 4.6mm dimensions and 5μm particle size with mobile phase containing 15mM ammonium acetate: methanol (70:30% v/v) was used at isocratic mode binary pump and eluents were monitored at 220nm. The retention time of Terbutaline sulphate was 4.1min and showed a good linearity in the concentration range of 2-10μg/mL with a correlation coefficient >0.999. The validation characteristics included specificity, linearity, and limit of detection, limit of quantification, precision, robustness and stability. Validation acceptance criteria were met in all cases. The percent recoveries ranged between 98-102%, RSD < 2%. The method could be successfully used for the analysis of Terbutaline sulphate in bulk, dosage forms and in dissolution samples of marketed Terbutaline sulphate tablets.