Analytical Method Development and Validation for Netupitant and Palonosetron in Combine Dosage form by RP-HPLC

Duvvani Pallavi¹*, Gope Edward Raju², Vaddi Lakshmi Priya³, Doonaboyina Raghava⁴, Kavala Nageswara Rao⁵
Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, A.P, India

A  B  S  T  R A C T
High performance liquid chromatography is at present one of the most sophisticated tool for analysis. The estimation of Netupitant and Palonosetron was done by RP-HPLC. The assay of Netupitant and Palonosetron was performed with tablets and the % assay was found to be 100.08 and 100.04 which shows that the method is useful for routine analysis. The linearity of Netupitant and Palonosetron was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision RSD should not be more than 2.0% and the method show precision 0.8 and 0.3 for Netupitant and Palonosetron which shows that the method is precise. The acceptance criteria of intermediate precision is RSD should not be more than 2.0% and the method shows precision 0.8 and 0.4 for Netupitant and Palonosetron which shows that the method is repeatable when performed in different days also. The accuracy limit is the percentage recovery should be in the range of 97.0% – 103.0%.  The total recovery was found to be 100.43% and 100.50% for Netupitant and Palonosetron. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ is 3 and 10. The LOD and LOQ for Netupitant was found to be 3.02 and 9.98 and LOD and LOQ for Palonosetron was found to be 3.00 and 10.00. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions.
Keywords: RP-HPLC, YMC column, Chromatography, Netupitant and Palonosetron.