Ranolazine

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.

In the present research work an attempt was made to formulate and evaluate  CR tablets of Ranolazine by using different polymers, polymers namely HPMC Phthalate and Eudragit S 100. Drug polymer interaction studies were carried out by using FTIR analysis which confirmed that there were no interactions between the drug and excipients. All the physical parameters of Drug & Drug – excipients (wet granules) carried out. The results indicate that all formulations were within the pharmacopoeial  specifications. The various formulations of CR tablets of Ranolazine were formulated by using various concentration different polymers HPMC Phthalate and Eudragit S 100. The tablets were evaluated for pre compression and post compression parameters and In-vitro dissolution. The results indicated that the, physical parameters of formulated tablets were within the Pharmacopeial specifications. The controlled release tablets of Ranolazine formulations was optimized on the basis of different physical parameters and mainly with the comparison of formulations on the basis of in-vitro dissolution study and the optimized formulation F4 were found to be 97.0 % drug release within 24 hours. The kinetic studies To know the kinetic drug release, the data was treated according to different model. The drug release data of F1-F5 fitted to Higuchi plots were best fit into Higuchi equation and diffusion mechanism. The zero order plots for all formulation were found linear. The result shows that, drug release rate for the F4 formulation follow the zero order mechanism. The accelerated stability studies of selected formulation (F4) showed that there were no significant changes.

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, precise, rapid and accurate reverse phase high performance liquid chromatography method (RP-HPLC) in isocratic mode has been developed for the estimation of ranolazine in pure form and in its tablet dosage form. An Agilent Eclipse XDB C18, 150 x 4.6 mm, 5mm particle size column, with mobile phase consisting of phosphate buffer pH 3.5 and acetonitrile in the ratio of 65:35 % v/v was used. The flow rate was 1.0 mL/min and the column effluent was monitored at 272 nm. The retention time was 4.7 min. The detector response was linear for ranolazine in the concentration range of 10-150 µg/mL. The limit of detection (LOD) was found to be 0.034 μg/mL. The limit of quantification (LOQ) was 0.102 μg/mL. The method was validated by determining its accuracy, precision and system suitability. 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 ranolazine in pure drug and in its tablet dosage form.