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.
ABSTRACT
A simple, specific, and accurate reverse phase liquid chromatographic method was developed for the estimation of Tizanidine (TZN) and Baclofen (BCF) in combination. A Phenomenex -C18 (150×4.60 mm Dimensions, 5μm Particle size) column with mobile phase containing methanol: water (53:47) was used at isocratic mode and eluents were monitored at 228 nm. The retention times of TZN and BCF were 2.03 and 4.1min respectively and both the drugs showed good linearity in the concentration range of 10-50 μg/mL with a correlation coefficient (R) of 0.9992 and 0.9993 respectively. The proposed method was validated as per ICH guidelines and method showed good precision with percent relative standard deviation less than 2%. The percentage assay values of TZN and BCF were found to be 99.72 and 98.56 respectively and recovery values are within the limits of 98-102% indicating the proposed method was accurate and precise for the simultaneous estimation of TZN and BCF in bulk and pharmaceutical dosage forms.