In the present paper a fundamental, affirmed dependability showing reverse phase RP-HPLC technique was imparted for palonosetron HCl in plan using Agilent C18 segment (250mm x 4.6mm I.D; atom size 5µm) with versatile stage comprising of acetonitrile and Buffer (pH-2.60±0.05) in the extent of 50:50 (%v/v) at a stream pace of 1.0ml/min with UV discovery of 237nm in room temperature. Palonosetron HCl continuously eluted at the maintenance time 3.880min ordinarily. The regression examination revealed a straight calibration bend inside the centralization of 10-30µg/ml (r2=0.9993) for palonosetron HCl only. Truthful results of Student's t-test (0.46) for precision and F-test (2.25) for accuracy revealed no basic differentiation between the proposed RP-HPLC strategy and the announced technique at the 95% certainty level with respect to Exactness. As the approval results were inside the cutoff purposes of the International Conference on Harmonization rules (ICH) it is closed, that the made RP-HPLC test method can be used for standard quality control examination by pharmaceutical associations.
Cite this article:
Suresh Gandi, A. Manikandan. Approved stability indicating Reversed-phase-high performance liquid chromatographic assay method for Palonosetron HCl in Formulations. Research J. Pharm. and Tech 2021; 14(3):1305-1309. doi: 10.5958/0974-360X.2021.00231.6
Suresh Gandi, A. Manikandan. Approved stability indicating Reversed-phase-high performance liquid chromatographic assay method for Palonosetron HCl in Formulations. Research J. Pharm. and Tech 2021; 14(3):1305-1309. doi: 10.5958/0974-360X.2021.00231.6 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-3-19
1. Stacher G. Palonosetron (Helsinn). Curr Opin Investig Drugs.2002; 3: pp.1502–1507.
2. Stoltz R, Cyong JC, Shah A and Parisi S. Pharmacokinetic and safety evaluation of Palonosetron, a 5- hydroxytryptamine-3 receptor antagonist, in US and Japanese healthy subjects. J Clin Pharmacol. 2004; 44:520–531.
3. United States Pharmacopeia. USP 34-NF 2011; 29.
4. Srikanth I, Ravikanth I and Venkatesh G. A validated novel RP-HPLC method development for the estimation of palonosetron hydrochloride in bulk and softule dosage forms. Der Pharmacia Sinica. 2011;2(5):223-234.
5. Zheng and Guo-gang. HPLC determination of palonosetron hydrochloride and its related substances. Chinese Journal of Pharmaceutical Analysis. 2010; 4:1264-1267.
6. Vishnu Murthy M and C. Krishnaiah C, Jyothirmayi K, Srinivas K, Ramesh Kumar M and Gautam Samanta. Enantio-separation of palonosetron hydrochloride and its related enantiomeric impurities by computer simulation and validation. American Journal of Analytical Chemistry. 2011; 2:437-446.
7. Jayesh D. Bodar, Sharad Kumar, Yogesh Chand Yadav, Seth AK and Gajanan J. Development of the chromatographic method for the estimation of palonosetron in palonosetron hydrochloride injection. Pharma Science Monitor. 2011; 2(3):24-31.
8. Pathi, JP. The estimation of palonosetron hydrochloride in parenterals by RP-HPLC- A Review. Asian Journal of Pharmaceutical Technology. 2012; 2(2):77-79.
9. Patel HP, Ladva BJ, Patel HK and Nayak BS. Stability indicating HPLC method for estimation of palonosetron hydrochloride in tablet dosage form. International Journal for Pharmaceutical Research Scholars. 2015;4(2):258-263.
10. Kalpana Nekkala, Shanmukha Kumar JV, Ramachandran D and Ramanaiah G. Development and validation of stability indicating RP-LC modus operandi for estimation of palanosetron in bulk and formulations. Journal of Chemical and Pharmaceutical Sciences. 2017; 10(1):616-621.
11. Kalavati. T, Shyamala and JVC Sharma. development and validation of stability indicating UPLC method for the estimation of palonosetron in bulk and its pharmaceutical dosage form. IJPPR. Human. 2019; 14(3):144-154.
12. International Conference on Harmonization. Validation of Analytical Procedures: Text and Methodology Q2(R1). Geneva: International Conference on Harmonization. Accessed 2013:5.