BACKGROUND: A simple, economic, selective, precise, and accurate High Performance liquid Chromatographic method for the analysis of Chloramphenicol in bulk drug and pharmaceutical formulations were developed and validated in the present study. The mobile phase, employed in the present study, consists of a mixture of sodium pentanesulfonate solution, acetonitrile, and glacial acetic acid in the proportion 85:15:1 respectively, the pH of the solutions was maintained at 5.0 ± 0.05 with sodium hydroxide solution . This was found to give a sharp peak of Chloramphenicol at a retention time of 3.551 min. HPLC analysis of Chloramphenicol was carried out at a wavelength of 272 nm with a flow rate of 2.0 ml/min. The linear regression analysis data for the calibration curve showed a good linear relationship with a regression coefficient of 0.999 in the concentration range of 50 μg ml-1to 150 μg ml-1. The linear regression equation was y =38.493x-51.484. The developed method was employed with a high degree of precision and accuracy for the analysis of Chloramphenicol. The developed method was validated for accuracy, precision, robustness, detection and quantification limits as per the ICH guidelines. The wide linearity range, accuracy, sensitivity, short retention time and composition of the mobile phase indicated that this method is better for the quantification of Chloramphenicol.
Key Words: Chloramphenicol. HPLC. Validation
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