ISSN : 2663-2187

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR THE SIMULTANEOUS ESTIMATION OF NEBIVOLOL AND CHLORTHALIDONE IN PHARMACEUTICAL DOSAGE FORM

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Kundan Deore, Ujash Shah
» doi: 10.33472/AFJBS.6.Si2.2024.1576-1590

Abstract

The new stability-indicating high performance liquid chromatography (HPLC) method has been developed and validated with different parameters for Nebivolol (NEB) and Chlorthalidone (CHL) in the combined dosage form. The chromatographic conditions were optimized using a mobile phase of Acetonitrile : 0.01M KH2PO4 buffer pH 3(OPA) (60 : 40 %v/v) with a flow rate of 1 mL/min. Cosmosil Column (C18) of 4.6 × 250 mm dimension was used as a stationary phase; the particle size capacity of the column was 5 µm. The detection was carried out at 226 nm. The method was validated according to ICH guidelines for linearity, precision, repeatability, the limit of detection (LOD), and limit of quantitation (LOQ). The response was found to be linear in the concentration range of 12.5 to 75 µg/ml for NEB and 31.25 to 187.5 µg/ml for CHL. The developed method shows the minimum quantity of drugs to be identified (LOD) and minimum drug to be quantified (LOQ). The LOD and LOQ were found to be 0.0059 and 0.018 respectively for NEB and 0.1 and 0.306 respectively for CHL. The method was linear, simple, precise, and accurate, therefore, suitable for routine analysis of drugs in tablet form. The forced degradation studies were also done through the exposure of analyte solution to four different stress conditions

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