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Abstract

Development and validation of a RP-HPLC method for determination of cyclosporine in capsule

Author(s): F Aziz, A Gupta, MF Khan
Ranbaxy Research Laboratories, R & D 3, Gurgaon-122 001, India

Correspondence Address:
F Aziz Ranbaxy Research Laboratories, R & D 3, Gurgaon-122 001 India E-mail: kashfi [email protected]


A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination of cyclosporine in capsule dosage form. XTerra C18 column was used as stationary phase with mobile phase acetonitrile in combination with 0.1% trifluoro acetic acid buffer and pH is adjusted to 1.4. Method was developed in an isocratic run of 20% trifluoro acetic acid with 80% acetonitrile for 10 min, at flow rate of 1 ml/min. Effluents were monitored at 210 nm. Retention time of cyclosporine was 3.855 min. The method was validated for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, robustness and solution stability. Limit of quantification and limit of detection of cyclosporine was found to be 100 ng/ml and 200 ng/ml. Recovery was found to be in the range of 98.08-101.55%. The proposed method was successfully applied for the quantitative determination of cyclosporine in a capsule dosage form.



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