Stability-indicating validated HPLC method for assay of Cyclosporine-A in bulk drug and ophthalmic formulations

G. S. Deshmukh, Ashish Kumar Sharma

Abstract


Objective: A stability-indicating high performance liquid chromatographic (HPLC) method for Cyclosporine-A in the presence of the degradation products generated in the stress degradation study.

Methods: This paper discusses the development of a stability-indicating reversed-phase HPLC method for analysis of cyclosporine-A as the bulk drug and in formulations. The mobile phase was acetonitrile–water 70:30 (v/v). The calibration plot for the drug was linear in the range 100 – 800 µg/mL.

Results: The method was accurate and precise with limits of detection and quantitation of 8.01 and 26.7 µg, respectively. Mean recovery was 100.04%.

Conclusions: The method was used for analysis of cyclosporine-A in pharmaceutical formulations in the presence of its degradation products and commonly used excipients.


Keywords


Column liquid chromatography, Cyclosporine-A, Stability-indicating, stress degradation

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