A VALIDATED REPORT ON FORMULATION STABILITY STUDIES OF BENDAMUSTINE HYDROCHLORIDEAbstract
The objective of this study was to adopt the analytical method. This adoption procedure was carried out by validating the method parameters and conducting the forced degradation studies to check the interference of the chromatographic response of the degradation products with the drug. In the present study an attempt was made to studies related to system suitability, linearity, accuracy, precision, and assay content, forced degradation, acid and base degradation, hydrolysis degradation and photo stability studies were conducted as per the standard procedures. System suitability conditions meet the recommended criterion. Linearity of the solution was demonstrated between 0.0002577 mg/ml and 0.51540 mg/ml concentration range. Recovery and % RSD are within the recommended limits. Injection reproducibility was demonstrated and the % relative standard deviation for retention time and area were within the limits. Limit of detection value is at 0.00004165mg/ml and limit of quantisation is at 0.00012621mg/ml. Solution was stable up to 38hrs at 5°C temperature. Precision was demonstrated and the percentage relative standard deviation for assay was within the limits. Specificity was also demonstrated and there was no interference with the diluent & mobile phase. Under forced degradation studies, the peak purity angle is always lower than purity threshold for Bendamustine hydrochloride and all degradant peaks were well resolved. Hence the method can be adopted for the formulation screening studies as a stability indicating method.
Niharika Sridasam*, Ravinder Reddy Y. and V. Kavya
Teegala Ram Reddy College Of Pharmacy, #4-202, Meerpet, Saroor Nagar (M), Ranga Reddy (Dist), Hyderabad-500079, Telangana, India
02 June 2014
12 August, 2014
22 September, 2014
01 January, 2015