Method Development and Analytical Method Validation of Carvedilol by High Performance Liquid Chromatography
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2016, Vol 11, Issue 6
Abstract
The goal of this study was to develop an easy, specific, accurate, precise and sensitive reversedphase high performance liquid chromatographic (RP-HPLC) analytical method for the rapid quantitative determination of Carvedilol. Carvedilol is widely used in the early treatment of mild to severe congestive heart failure (CHF) and high blood pressure as it is a nonselective beta blocker/alpha-1 blocker. The chromatographic separation was carried out on Shimadzu 20-A series equipped with solvent delivery pump LC20AT,autosampler SIL-20ACHT, PDA detector SPD-M20A and degassing unit. The HPLC column was Hibar® (250mm x 4.6mm, 5µm) C18 RP and perchlorate buffer (pH 2.0), Acetonitrile and Triethylamine in proportion of (45:55:0.3 V/V/V) as mobile phase at 1.0 mL/min flow rate while 240 nm wavelength used as UV detection. The ICH guideline Q2(R1) approach used for the Method Validation of this Analytical Procedures. The method found linear around the range of 1.88µg/mL to 11.25µg/mL with a (r2 = 0.9997) with adequate level of accuracy and precision. The method has shown acceptable level of robustness with repeatability, reproducibility and intermediate precision. The proposed method can be confidently employed with adequate level of assurance for the routine testing of carvedilol in pharmaceutical dosage form.
Authors and Affiliations
Abdullah . , Waqas Jamil, Hira Shariq3, Jawaid Ahmed Siddiqui4
Keywords
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