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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 10
First page : ( 5007) Last page : ( 5010)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00868.0

Development and Validation of UV Spectroscopic Method for the Determination of Ranolazine in Bulk and Formulation

Doppa DVS Roopa Sirisha*, Konidala Sathish Kumar, Khanabhi Sheik

Assistant Professor, Department of Pharmaceutical Analysis and Quality Assurance, Koringa College of Pharmacy, Korangi, Tallarevu Mandal, E.G., Andhra Pradesh, India-533463

*Corresponding Author E-mail: sirisharoopa222@gmail.com

Online published on 24 December, 2019.

Abstract

Objective

To develop a new UV-Spectrophotometric method for the determination of Ranolazine in bulk and pharmaceutical dosage form.

Method

The method was developed using 0.2% v/v ortho phosphoric acid as solvent after many trail and errors for determining the absorption maxima at 271 nm. Different dilutions ranging from 20 to 100μg/ml were prepared from stock solution (1mg/ml) solution and their absorbance was measured at 217 nm.

Result

The developed method was validated according to ICH for different parameter like linearity, precision, Accuracy, robustness, ruggedness, LOD and LOQ. Result indicating that the validation parameters are within the limits, the correlation coefficient (r2) is found to be 0.999, % RSD value obtained by precision is 0.590,% recovery of the drug is 97.25–97.75%, LOD and LOQ values were found to be 0.807 and 2.4460μg/ml, y=0.006 x-0.0048 is the linear equation obtained from calibration curve, % RSD obtained by robustness was 0.00086, % purity obtained by assay was 101.01%.

Conclusion

From the results we concluded that the method can be used for the determination of Ranolazine in routine analysis in quality control of pure and pharmaceutical dosage form without the interference of excipients.

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Keywords

Ranolazine, UV-spectrophotometry, 0.2% v/v Ortho phosphoric acid, Method development, Validation.

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