STABILITY INDICATING HPLC METHOD FOR RILPIVIRINE AND DOLUTEGRAVIR SODIUM
Mrinalini C. Damle* and Amita N. Pardeshi
ABSTRACT
Objective: To develop and validate stability indicating HPLC method for determination of Rilpivirine and Dolutegravir Sodium. Methods: The HPLC method was developed using mobile phase pH adjusted to 3 (Distilled water: MeOH) (40:60) v/v stationary phase was HiQSiL C18 Column (250* 4.6 mm) at the flow rate 1 ml/min. The retention time for the drug was found to be: Rilpivirine = 4.54 ± 0.2 min, Dolutegravir Sodium = 10.04 ± 0.2 min.The eluted compounds were detected using PDA detector. Result: The drugs were subjected to stress testing as per ICH Q1A (R2). There was no interference of any degradant at RT of Rilpivirine and Dolutegravir Sodium. The developed method was successfully validated according to ICH Q2R1 guidelines. The calibration curve was found to be linear over a range of 10 - 50 μg/ml. The accuracy of the method is indicated by good recovery in the range of for Rilpivirine 99.52% - 101.48% and of Dolutegravir Sodium 97.02% - 111.97. The limit of detection and limit of quantification of Rilpivirine was found to be LOD-1.743 μg/ml and LOQ-5.284 μg/ml and for Dolutegravir Sodium was found to be LOD-1.267 μg/ml and LOQ-3.840μg/ml. Conclusion: A new simple, accurate, precise and specific stability- indicating high performance liquid chromatographic (HPLC) method has been developed and validated for determination of Rilpivirine and Dolutegravir Sodium in combination.
Keywords: Stability Indicating, HPLC, Rilpivirine and Dolutegravir Sodium.
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