Validation of Liquid Chromatographic Analytical Method for Determination of Cephalexin and Aspirin in Pure and Pharmaceutical Preparations
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Author:
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AHMED MAHDI SAEED, MOHAMMED JASSIM HAMZAH, OMER JASIM MOHAMMED
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Abstract:
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In this research, an accurate, efficient and reproducible isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been modified and set for the determination of Cephalexin (CEP) and Aspirin (ASP) as pure and in formulated form. A mixture of drugs as standard material and in formulation tablets were separated using an phenomenex C18 column, (L, 15 cm, I.D, 0.46 cm, and Size of particle, 5 µm), with the shimadzu RP – HPLC, model LC–20 - A, Japan. The eluent phase was optimized through the design, experiment. Elution was done by an eluent phase composed of water (H2O) and acetonitrile (ACN) mixture have a ratio of (60: 40 V/V), with adjusted pH of 4.0 with acetic acid, have a pumped flow rate of 0.8 mL/min. The separation of drugs was done using a UV-VIS - detector at 270 nm for 4 min. The time of elution for the drugs was recorded at (1.981 and 3.072 min) for ASP and CEP respectively. The optimum conditions such as the composition of the mobile phase, flow rate, wavelength and pH were studied. Calibration graph was in the range of concentration (1 - 50 µg/mL) for the two drugs. While, R2 values within (0.9996 and 0.9993), and the means of recovery were found within (99.77 – 100.16) for ASP and CEP. The LOD were found to be 0.05 µg/mL for ASP and CEP. The values of LOQ were 0.165 µg/mL for ASP and CEP.
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Keyword:
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Determination, RP - HPLC, recovery, isocratic.
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EOI:
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-
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DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.250
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