ABSTRACT

The present work describes a simple, reproducible, economical and rapid analytical method for the determination of Risperidone and its application in commercially available dosage form. In this respect RP-HPLC and UV/Visible Spectrophotometric methods were developed and validated for estimation of Risperidone in Pharmaceutical Formulations. In HPLC method the separation of analyte was carried by using Octadecylsilane Column C18 (4.6mm x15 cm) and mobile phase having fixed composition of Water and Acetonitrile in the ratio of 65:35 v/v was used at pH 3.0 and at a flow rate of 1.0 ml/min. Detection was carried out at 275 nm. Retention time for Risperidone was found to be 5.097 min, while in spectrophotometric method the ? max of the Risperidone was determined by performingrepetitive scans of Risperidone sample solutions in the entire UV region. Only one peak was observed in all scans at wavelength of 237 nm.Standard and Sample solutions were made in 0.2 N HCl. In both the HPLC and UV/Vis. spectrophotometric methods, the mean content of Risperidone in the five different brands of tablets were within the USP limit i.e. 95%-110%. Thus it was proved that the proposed HPLC method can be successfully used for the commercially available resperidone brands. The developed methods were validated in accordance with the current International Conference on Harmonization guidelines and validated against certain parameters like Accuracy, Precision, Specificity, Linearity, Robustness, Limit of Detection (LOD) and Limit of Quantitation (LOQ). Keywords: Risperidone, RP HPLC, Validation, UV/Visible, USP

https://ijbpas.com/pdf/2018/March/1519918362MS IJBPAS 2018 4383.pdf

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