An oral fixed dose combination of netupitant as highly selective NK1 receptor antagonist and palonosetron as 5-HT3 receptor antagonist indicated for the prevention of chemotherapy induced nausea and vomiting (CINV). The shelf life of the product specifies the length of the period in which it remains fully effective under normal storage conditions and it was established by performing forced degradation studies. The current study was focussed to perform forced degradation studies for the combined capsule dosage form containing netupitant and palonosetron and to develop a stability indicating assay for the estimation of their potency simultaneously using isocratic RP-HPLC method with diode detection along with their degradation products. Optimized chromatographic conditions were established for the efficient separation and quantification of netupitant and palonosetron in the presence of their degradation products with excellent resolution and selectivity. The chromatographic separation of netupitant and palonosetron was achieved with a combination of an analytical C18 column (250 x 4.6 mm, 5m) as stationary phase, maintained at ambient temperature and mobile phase comprising of buffer and acetonitrile in the proportion of 62:38 (v/v) as mobile phase, pumped on to the column in isocratic mode at a flow rate of 1.0 ml/min. The eluents from the column were monitored at a wavelength of 254 nm using diode array detector and also performed peak purity analysis for detecting the co-eluting degradation products to ensure the accuracy of the quantification. Netupitant and palonosetron are subjected to acid, base, water, hydrogen peroxide, temperature, humidity and light to know the extent of degradation. The established method well separated the netupitant and palonosetron with their co-eluting peaks of degradation products with required resolution and selectivity and allowed to quantify simultaneously without any interference, demonstrating the stability indicating nature of the method. To know the stability indicating nature of the proposed RP-HPLC method, it was statistically validated as per international conference on harmonization (ICH) with respect to linearity, specificity, precision, accuracy and robustness, limit of detection and limit of quantification, including system suitability. The proposed method was found to be specific, selective, simple, rapid, economic, accurate and precise method and it could be suitable for routine laboratory analysis.
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