A sensitive, rapid, precise, accurate high-performance liquid chromatographic method was developed for the estimation of Sorafenib (SOR) in the tablet dosage form. Chromatographic separation of SOR was carried out utilizing thermo-scientific model C18 column (4.6 mm i.d. X 250 mm; 5µm particle size) (based on 99.99 % ultra-high purity silica) using mobile phase that consisting of acetonitrile: methanol (40:60 v/v) at a flow rate of 1.0 mL/min. The absorption maximum (?max) of SOR in the mobile phase was found to be 265.5 nm. It had a retention time of 3.223 min. The calibration curve was in linear function of the drug in the concentration range of 2-10 µg/mL (r2 = 0.999) for the optimized method. The regression equation for SOR was found to be Y = 68228 x + 8071. The Detection Limit (DL) & Quantitation Limit (QL) results of SOR were found to be 0.526 µg/mL and 1.594 µg/mL respectively. The developed method was validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 - 102 %, and minimum values of % RSD indicate the accuracy of the method. The detailed quantitative results of the study show that this method is precise, accurate, and cost-effective. Thus, the developed RP-HPLC method can be successfully feasible for the routine quality control analysis of SOR in a pharmaceutical dosage form.

A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantification of Rivaroxaban in Bulk drug and Pharmaceutical dosage form. The quantification is carried out with a Nucleosil C18, (250 × 4.6 mm, 5 µm) column maintained at room temperature with mobile phase consisted of a mixture of acetonitrile and water in the ratio of 50:50 (v/v) delivered at a flow rate of 1.0 ml / min and effluents were monitored at 251 nm through PDA detector. The total run time was set at 7 min. The retention time of Rivaroxaban was found to be 4.893 min. The method was validated as per ICH guidelines, parameters like linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. The linearity was in the range of 5-50 µg/ml with correlation coefficient of 0.9992. The recovery of rivaroxaban was found to be 98.84 %. Limit of detection and limit of quantification were found 0.054 µg/ml and 0.164 µg/ml respectively. The proposed method was successfully applied for the quantitative determination of Rivaroxaban in tablet dosage form in quality control testing laboratories.

No abstract

Memantine hydrochloride is a new member of the adamantane family and likewise, it shares the non-chromophoric structural feature characterizing these compounds. It is approved for the treatment of moderate to severe Alzheimer's disease. In this work, we present two simple and sensitive spectrophotometric methods for its determination.Method I is based on forming a coloured binary complex with Bromocresol Green (BCG) in potassium hydrogen phthalate buffer (P H 3) which are extracted into chloroform and have absorption maxima measured at 420 nm, while method II uses its reaction with picric acid in chloroform to form a yellow coloured ion pair complex.Which are extracted in the chloroform and have measured at 430 nm.Regression analysis showed good linearity over the concentration ranges of 3-18 and 5-30 μg/mL for method I and II respectively with correlation coefficient values >0.999. The applicability of the proposed methods was evaluated through the analysis of tablets and satisfactory recoveries were obtained. Moreover, the statistical comparison of the obtained results with those of the reference method revealed no significant differences. Thus, the simplicity and high sensitivity of the proposed methodologies can verify their suitability for the routine analysis of memantine hydrochloride in its tablet formulations.

No abstract