Qbd Based Novel Rp Hplc Stability Indicating Method For The Estimation Of Voclosporin In Bulk And Its Dosage Form

Abstract

A simple, specific, sensitive, rapid, precise, accurate, robust, and stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method by using QBD has been developed for the quantitative analysis of Voclosporin in pharmaceutical dosage form.

Chromatographic separation of Voclosporin was achieved on Waters Alliance-e2695 by using Waters X-Terra RP-18 (250x 4.6mm, 5μ) column and the mobile phase containing Acetonitrile: Potassium dihydrogen phosphate in the ratio of 49.1:51% v/v. The flow rate was 0.9 ml/min; detection was carried out by absorption at 231nm using a photodiode array detector at ambient temperature.

The number of theoretical plates and tailing factor for Voclosporin were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0 respectively.

The validation was carried out an optimized method and obtained results were within the limits of acceptance criteria for all the parameters like System suitability, Specificity, Linearity, Accuracy, Precision, LOD, LOQ, Robustness and stability of the method has been checked by the forced degradation studies. Based on the above information the method can be used for the daily routine analysis.