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Analytical Method Development and Validating the Estimation of Pregabalin in bulk and its Formulation using RP-HPLC
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| Author:
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BIRENDRA SHRIVASTAVA, SAI RAJESH KOLLAPUDI, DINAKAR A
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| Abstract:
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Pregabalin is an antiseizure drug that is used to treat neuropathic pain, and as an adjuvant in the partial seizures and GAD. It binds with the alpha delta site with very high affinity in the CNS. Though the mechanism of the drug is unknown, results suggested that it binds to the alpha receptors in genetically modified mice and other anticonvulsive models. It is often misused and classified as a Schedule V drug in the U.S. There had been a rapid increase in the number of drugs that are adding to each class of drugs. These drugs are formulated into newer formulations either in a single or multi-drug dosage forms. These newer marketed formulations demand a new investigation for the estimation of the drug in the formulations. The existing analytical techniques for those drugs are available in the research literature, but not all the methods are stable and economical to use. Few other methods are time-consuming too. The objective of this work was to develop an analytical RP-HPLC method for the estimation of Pregabalin in bulk and tablet formulation. RP-HPLC analysis of the drug satisfies the peak integrity, suitability, recovery of the drug. LOQ and LOD of the drug were achieved with high sensitivity. The data shows the precision of the method and the accuracy of the method. Overall, the data suggest that the proposed analytical method can be used to analyze the drug in the formulation. This method can be recommended for the routine analysis of the drug in its dosage form.
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| Keyword:
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Pregabalin, RP-HPLC, Mobile phase, Retention time, ICH guidelines
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.487
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| Download:
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