Abstract :
A simple, novel, sensitive and precise validated spectrophotometric method was developed for simultaneous determination of Mebendazole (MBZ) and Levamisole Hydrochloride (LVM) in its tablet formulation. 1% H2SO4 in methanol was selected as a common solvent for estimation of MBZ and LVM. For first order derivative method, estimation of MBZ was carried out at 307nm (ZCP of LVM) and of LVM at 232.6nm (ZCP of MBZ). The linearity was obtained in the concentration ranges of 2-6 ?g/mL for MBZ and 3-9 ?g/mL for LVM with correlation coefficient(r2) value greater than 0.995 . The % RSD value for intraday & interday precision were less than 2. The detection limit and quantification limit were found to be 0.44 ?g/mL and 1.34 ?g/mL for MBZ and 0.14 ?g/mL and 0.42 ?g/mL for LVM, respectively. All the validation parameters were performed as per the ICHQ2 (R1) guidelines. The recovery study was carried out, results were 98.82 – 101.93 % for MBZ and 100.05-101.42% for LVM. So, the developed method could be applied for the routine quality control analysis of MBZ and LVM in combined tablet formulation.
Keyword :
Mebendazole, Levamisole Hydrochloride, First Order Derivatives, ICH guideline, Validation