Linearity

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Ranolazine in tablet dosage form. The drug is freely soluble in analytical grade methanol. The drug was identified in terms of solubility studies and on the basis of melting point which was done on melting point apparatus of Equiptronics. Ranolazine 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 Ranolazine in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade methanol, slightly soluble acetonitrile and very slightly soluble in analytical grade water. So, the analytical grade methanol is used as a diluent in method. The melting point of Ranolazine was found to be 120-122ËšC (uncorrected). It showed absorption maxima 235 nm in analytical grade methanol. On the basis of absorption spectrum the working concentration was set on 8 µg/ml (PPM). The linearity was observed between 2-12 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 98.33% for three levels respectively. The % RSD for precision was found to be 0.6353% which was within acceptance criteria as per ICH guidelines. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Ranolazine in tablet dosage form. The method could be considered for the determination of Ranolazine in tablet dosage form in quality control laboratories.

The objective of the present research work is to develop and validated analytical method for the determination of Darunavir in pure and tablet dosage form. A simple, rapid, precise, selective and accurate novel RP-HPLC method was developed and validated for separation and determination for the Darunavir in pure and tablet dosage form. Darunavir was analyzed by Zodiac C18, (250×4.6mm, 5µ), Shimadzu LC-20AT Prominence Liquid Chromatograph and mobile phase constituted of Triethylamine buffer: Acetonitrile (60:40 v/v). The pH of the buffer was adjusted to 4.5 with diluted ortho-phosphoric acid. The flow rate of mobile phase was 1.0 mL/min and the analysis was performed using UV-Visible detector at 260nm. The Darunavir was eluted with in 6 min and retention time was showed 2.753 min. The developed assay method was validated by the guidelines of ICH Q2R1.The method was found to be linear in the drug concentration range of 20 µg/mL -100 µg/mL. The value of correlation coefficient was found to be 0.999. Method was found good percentage recovery it indicate the method is highly accurate. The method has been successfully applied for determination of Darunavir in pharmaceutical dosage form in regular quality control analysis.

This present study was undertaken with an objective to develop & validate a simple, precise, cost effective, sensitive & fast RP- HPLC method for the analysis of Ranolazine. A Shimazu HPLC system with Luna 5µm C18 is employed for the analysis using Methanol: Acetonitrile(50:50, v/v) as mobile phase. Signal from Ranolazine is detected at 227nm by UV Spectrophotometer. The total retention time was 5 min with a flow rate of 1.0 ml/min. % 0f RSD values for precision is found to be 0.798%.The limits of detection (LOD) and quantification (LOQ) were 0.616 and 1.86, respectively. As per ICH guidelines the proposed method is fully validated and found to be linear over a workable drug concentration, accurate, precise and robust. This fast, simple and inexpensive method is suitable for research laboratories & also for quality control analysis in pharmaceutical industries.

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method is developed and validated for the estimation of Dapsone in tablet dosage form. The expected separation and peak shapes were obtained on Luna C18, 15 cm x 4.6 mm (5 μm)  column. To have an ideal separation of the drug under isocratic conditions, mixtures of solvents like methanol and water with or without different buffers indifferent combinations were tested as mobile phases on a Luna C18, 15 cm x 4.6 mm (5 μm) column. A mixture of Methanol:Water in the ratio of 40:60 v/v was proved to be the most suitable of all the combinations since the chromatographic peak obtained was better defined and resolved and almost free from tailing.  The flow rate was 1.0ml/min and effluents were monitored at 260 nm. The retention time for Dapsone was ± 2.4 min. The method was validated for accurate, precise, simple, sensitive and rapid and can be applied successfully for the estimation of Dapsone in bulk and in pharmaceutical formulations without interference and with good sensitivity. And recovery of Dapsone from tablet formulation was found to be 93%. The proposed method was successfully applied for the quantitative determination of Dapsone in tablet formulation.