Saturday , 8 May 2021

Method Development, Validation and Stability Studies of Nutipotant and Palanosetran in Pharmaceutical Dosage Form by RP-HPLC

Baddam Anusha, P. Sirisha*
Joginapally B.R. Pharmacy College, Yenkapally, Moinabad, Hyderabad, Telangana500075.

ABSTRACT
A new method was established for simultaneous estimation of Nutipatant and Palonosetran by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Olmesertan medoxomil and Chlorthalidone by using YMC 4.6*150mm 5µ, flow rate was 1.0ml/min, mobile phase ratio was 70% buffer and 30% methanol, detection wave length was 210nm. The instrument used was SHIMADZU HPLC Auto Sampler, Separation module 2695, UV Detector 2998, Empower-software version-2. The average retention times for Nutipatant and Palonosetran was found to be 2.2 and 3.0 min, respectively. The estimation of Nutipatant and Palanosetran was done by RP-HPLC. The assay of Nutipatant and Palanosetran 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 Nutipatant and Palanosetran 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 is RSD should be not more than 2.0% and the method show  precision 0.8 and 0.3 for Nutipatant and Palanosetran which shows that the method is precise. The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show  precision 0.8 and 0.4 for Nutipatant and Palanosetran 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 Nutipatant and Palanosetran. 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 Nutipatant was found to be 3.02 and 9.98 and LOD and LOQ for Palanosetran 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: Nutipatant, Palonosetran, LOD and LOQ, HPLC

Scroll To Top