Abstract

Method development and validation of reverse phase high performance liquid chromatography (RP-HPLC) method to determine carvedilol in pharmaceutical formulations

The aspire of the present study was to explain development and consignitive validation of a reverse phase High performance liquid chromatography(RP-HPLC) method for estimation of Carvedilol, an antihypertensive drug in pharmaceutical formulations like tablets and nanoparticles. The chromatographic system consist of a steel plated C18 column, an isocratic mobile phase composed of phosphate buffer pH 3.0, acetonitrile and water (75:625:300) and UV detection at 240.0 nm.Carvedilol was eluted at 2.8 minutes without any interfering peak of other excipients used for the preparation of dosage form. The linearity was observed over the range from 1 to 50 μg/mL (R2 = 0.9999). The intra-day and inter- day precision values were in the range of 0.123-0.276 %.Limit of detection and limit of quantitation were 0.321 μg/mL and 0.721 μg/mL, respectively. All results were validated statistically according to ICH guideline for both tablets and nanoparticles. The release followed the Higuchi kinetic model, indicating diffusion dominated drug release.
Author(s): Sovan Lal Pal, Utpal Jana. G. P. Mohanta and P. K. Manna

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