Assay

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.

Levocetirizine Dihydrochloride is an orally active, non-sedative antihistamine drug. To determine the assay content of Levocetirizine Dihydrochloride drug substance, a very simple, accurate, specific and precise UV- spectrophotometric method has been built up as well as evaluated. The suggested method comprises dissolving Levocetirizine Dihydrochloride in 0.1M Hydrochloric acid solution and subjecting the consequential solution to UV Spectroscopic measurement. An Absorption maximum was found to lie at about 231nm and the measurements were carried out at this wavelength. Beer's law was followed in the concentration range of 7.5 to 22.5 μg/mL. The linearity showed on the calibration curve between concentration and absorbance by the line equation of y = 0.0377x - 0.0043 (R² = 0.9992). Reproducibility by repeating methods as %RSD was found to be less than 2%. The results of the accuracy and precision were found very satisfactory and here the suggested method was statically validated as per the ICH guidelines in terms of the specificity, linearity, accuracy, precision and robustness. Validation studies have discovered that the method is simple, specific, rapid, reproducible, precise, accurate and economical which is useful for the routine analysis of Levocetirizine Dihydrochloride

This paper deals with the development and validation of stability indicating an isocratic high performance liquid chromatographic method for the quantitative determination of memantine hydrochloride. The method is simple, highly sensitive, selective and is capable of quantitative determination of memantine hydrochloride. The chromatographic separation is achieved by injecting 20µL standard solution of memantine hydrochloride into HPLC system with refractive index detector using a YMC ODS-AQ, 5µm (150 x4.6)mm column. The mobile phase consists of 10 mL Triethylamine in 1L water(pH 5.5 adjusted with glacial acetic acid):MeOH in the ratio of  40:60 v/v. The flow rate was set at 0.9 ml/min with column and cell temperatures at 40˚C and 50 ˚C respectively and runtime was optimized to 10 min. Forced degradation studies were performed on bulk sample of memantine hydrochloride using acid (5.0Nhydrochloric acid) ,alkali (1.0N sodium hydroxide),oxidation (30% hydrogen peroxide),thermal(105 ˚C),photolytic and humidity conditions. The peak purity was checked with LC-MS and LC-MS/MS. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness, stability of analytical solution and robustness.