Lansoprazole

The proton pump inhibitor are rapidly degraded in the acidic medium Thus it has less bioavailability since it is acid labile , mostly available in  the enteric coated tablet to prevent acids degradation .But the onset of action is delayed. It is a great challenge to formulate simple compression solid dosage form of these drugs with considerable stability and efficacy. The Cocrystals of Lansoprazole was prepared by solvent evaporation using nicotinamide as a coformer. The prepared cocrystals were characterized by FTIR, SEM, DSC and XRD study. The cocrystals also evaluated for solubility and acid stability studies. The formation of Lansoprazole cocrystals were confirmed using FTIR, DSC showed the decreased in the melting point of cocrystals corresponds to melting point of pure Lansoprazole. The SEM also confirmed the changes in the habit of crystals. The acid stability study performed using HPLC and confirmed that the Cocrystals of Lansoprazole stable upto 75 % than the pure lansoprazole in 0.1 N HCL.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lansoprazole in Capsule dosage form. The drug is soluble in analytical grade Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Lansoprazole in Capsule dosage form and also validated as per ICH guidelines. The drug is freely soluble in Dimethylformamide, soluble in analytical grade Methanol, sparingly soluble in Ethanol, slightly soluble in Ethyl Acetate, Dichloromethane and Acetonitrile. So, the analytical grade Methanol is used as a diluent in method. The melting point of Lansoprazole was found to be 179-180ËšC (uncorrected). It showed absorption maxima 285 nm in analytical grade Methanol. On the basis of absorption spectrum the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 99.00 and 100.80 % for three levels respectively. The % RSD for precision was found to be 0.9039 %.A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lansoprazole in Capsule dosage form. The method could be considered for the determination of Lansoprazole in quality control laboratories.

A simple Reverse phase liquid chromatographic method has been developed and subsequently validated for estimation of lansoprazole in tablet dosage form. The separation was carried out using a mobile phase consisting of Methanol and 0.1% OPA (Ortho Phosphoric Acid) in the ratio of 70:30. The column used was C18 and 250 mm length with flow rate of 1.2 ml / min using UV detection at 285nm. The described method was linear over a concentration range of 10-50 μg/ml for the assay of Lansoprazole. The retention time of Lansoprazole was found to be 6.6 min, and all the results of analysis were validated statistically. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Lansoprazole in tablet dosage form and in its pharmaceutical dosage forms.