A Photo Stability Indicating HPLC technique for Validation of Netupitant and Palonosetron in Bulk and Formulations
Analytical chemistry is the science that seeks ever improved means of measuring the chemical composition of natural and artificial materials.Netupitant Delayed emesis has been largely associated with the activation of tachykinin family neurokinin 1 receptors. Palonosetron is a selective serotonin 5-HT3 receptor antagonist. The antiemetic activity of the drug is brought about through the inhibition of 5-HT3 receptors present both centrally and peripherally in turn inhibits the visceral afferent stimulation of the vomiting center.The mobile phase used was orthophosphoric and acetate 70% buffer pH 3 and 30% methanol.The assay of Netupitant and Palanosetron was performed with tablets and the % assay was found to be 100.08 and 100.04, The linearity was found to be linear with a correlation coefficient of 0.999, the precision 0.8 and 0.3 for Netupitant and Palanosetron which shows that the method is precise.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 LOD and LOQ for Netupitant were found to be 3.02 and 9.98 and LOD and LOQ for Palanosetron was found to be 3.00 and 10.00. Thus, it shows that the method is stability indicating, sensitive, accurate, robust and precise. Hence, the developed HPLC method can be successfully applied to the pharmaceutical dosage form and can be used for routine analysis.
Douglas A.Skoog, F. James Holler & Stanley R. Crouch. Instrumental analysis, India edition, 2007, pg: 13-14.
Ahuja S & Dong MW. Handbook of Pharmaceutical Analysis by HPLC. 1st edition, Academic Press Publisher.UK 2005.
Panigrahy, U. P., & Reddy, A. S. K. (2015). A novel validated RP-HPLC-DAD method for the simultaneous estimation of Netupitant and Palonosetron in bulk and pharmaceutical dosage form with forced degradation studies. International Journal of ChemTech Research, 8(10), 317-337.
Inturi, S., Inturi, R. K., & Venkatesh, G. (2011). A Validated Novel RP-HPLC method development for the estimation of Palonosetron Hydrochloride in bulk and softule dosage forms. Der Pharmacia Sinica, 2(5), 223-234.
Mangesh Harole, R. N. Patil and Deepak Gaware, (2016).A Validated Stability Indicating RP-HPLC Method For Simultaneous Determination Of Netupitant and Palenosetron In Pharmaceutical Formulations, World Journal Of Pharmacy And Pharmaceutical Sciences, 5(3),878-887.
Bhagavanji, N. V. M. S., Satyanarayana, P. V. V., Sekhar, K., & Naniprasad, D. (2016). Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Netupitant and Palonosetron in Combined Tablet Dosage Form. Int J Pharm Sci Rev Res, 41(1), 81-87.
ICH, Harmonized Tripartite Guideline, Validation of Analytical procedure: Text and Methodology, Geneva, Switzerland. 2006.
ICH, (Q1B), Harmonized Tripartite Guideline, Stability testing: Photo stability testing of New Drug Substances and Products, in: Proceeding of the International Conference on Harmonization, Geneva. 1996..
Copyright (c) 2020 Patta Salomi, Bathala Sireesha, Afreen sultana, Ravindra Reddy
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.