METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTIFICATION OF NETUPITANT AND PALONOSETRON IN BULK AND PHARMACEUTICAL DOSAGE FORM AND THEIR FORCED DEGRADATION STUDY BY RP-HPLC

  • MANORANJANI M Department of Chemistry, PB Siddhartha College of Arts and Science, Vijayawada, Andhra Pradesh, India.

Abstract

Objective: The present paper describes a simple, accurate, and precise reversed-phase high-performance liquid chromatography (HPLC) method for rapid and simultaneous quantification of netupitant (NTP) and palonosetron (PLS) in bulk and pharmaceutical dosage form.


Methods: The chromatographic separation was achieved on Luna C18 (250 mm × 4.6 mm, 5 μ). Mobile phase contained a mixture of 0.1% orthophosphoric acid and acetonitrile in the ratio of 60:40 v/v, flow rate 1.0 ml/min, and ultraviolet detection at 222 nm.


Results: The proposed method shows a good linearity in the concentration range of 60–900 μg/ml for NTP and 0.1–1.5 μg/ml for PLS under optimized conditions. All the precision and recovery results are in between 98 and 102%. In the entire robustness conditions, percentage of relative standard deviation is <2.0%. Degradation has minimum effect in stress condition and solutions are stable up to 24 h. This method is validated different parameters such as precision, linearity, accuracy, limit of detection, limit of quantification, ruggedness, robustness, and forced degradation study were determined according to the International Conference of Harmonization (ICH) Q2B guidelines.


Conclusion: All the parameters of validation were found to be within the acceptance range of ICH guidelines. Since there is no HPLC method reported in the literature for the estimation of NTP and PLS in pharmaceutical dosage forms, there is a need to develop quantitative methods under different conditions to achieve improvement in sensitivity, selectivity, etc. Hence, the author has attempted to develop a validation and forced degradation for simultaneous quantification of NTP and PLS.

Keywords: Reversed-phase-high-performance liquid chromatography, Netupitant, Palonosetron.

References

1. Quinla JD, Hill DA. Nausea and vomiting of pregnancy. Am Fam Physician 2003;68:121-8.
2. Christof S, Peters P, Miller RK. Antiemetics and hyperemesis gravidarum. Drugs During Pregnancy and Lactation: Handbook of Prescription Drugs and Comparative Risk Assessment. New York: Elsevier; 2001.
3. Paula G, Axel G, Loprinzi CL. Nausea and Vomiting in the Cancer Patient. New York: Springer; 2006. p. 1482-96.
4. Judith ET. Emergency Medicine: A Comprehensive Study Guide. New York: McGraw-Hill Companies; 2010. p. 830.
5. Corrie PG, Pippa G. Cytotoxic chemotherapy clinical aspects. Medicines 2008;36:24-8.
6. Levi JA, Aroney RS, Dalley DN. Haemolytic anaemia after cisplatin treatment. Br Med J (Clin Res Ed) 1981;282:2003-4.
7. Barnes NM, Hales TG, Lummis SC, Peters JA. The 5-HT3 receptor-the relationship between structure and function. Neuropharmacology 2009;56:273-84.
8. Purves D, Augustine GJ, Fitzpatrick D. Neuroscience. 4th ed. Sunderland (MA): Sinauer Associates; 2008. p. 11-20.
9. Berthoud HR, Neuhuber WL. Functional and chemical anatomy of the afferent vagal system. Auton Neurosci 2000;85:1-7.
10. Saunders CJ, Christensen M, Finger TE, Tizzano M. Cholinergic neurotransmission links solitary chemosensory cells to nasal inflammation. Proc Natl Acad Sci U S A 2014;111:6075-80.
11. Lutz DS. Dictonary of Minor Planet Names-Posterma. Berlin Heidelberg: Springer; 2007. p. 118.
12. Pietra S. Indolic derivatives II. A new way to synthesize serotonin. Farmaco Sci 1958;13:75-9.
13. de Lartigue G, Ronveaux CC, Raybould HE. Deletion of leptin signaling in vagal afferent neurons results in hyperphagia and obesity. Mol Metab 2014;3:595-607.
14. Pathi PJ, Raju NA. The estimation of palonosetron hydrochloride in parenterals by RP-HPLC. Asian J Pharm Tech 2012;2:77-9.
15. Inturi S, Inturi RK, Venkatesh G. A validated novel RP-HPLC method development for the estimation of Palonosetron hydrochloride in bulk and softule dosage forms. Pharm Sin 2011;2:223-34.
16. Murthy MV, Krishnaiah C, Kodithyala J, Katkam S, Mukkanti K, Ramesh K, et al. Enantio separation of palanosetron hydrochloride and its related enantiomeric impurities by computer simulation and validation. Am J Anal Chem 2011;2:437-46.
17. Jain PS, Chavan RS, Bari PR, Patil SS, Surana SJ. Stability indicating HPTLC method for estimation of palonosetron hydrochloride in tablet dosage form. J Adv Drug Deliv 2015;2:578-86.
18. Patel H, Lava B. Stability indicating HPLC method for estimation of Palonosetron hydrochloride in tablet dosage form. Int J Pharm Res Sch 2015;4:258-63.
19. Jayesh B, Sharad K, Yoges Y. Development of chromatographic method for the estimation of palonosetron hydrochloride injection. Indian J Pharm Sci 2011;2:24-32.
20. Harole M, Patil RN, Gaware D, Suryawansh G, Pise K. A validated stability indicating RP-HPLC method for simultaneous determination of netupitant and palonosetron in pharmaceutical formulations. World J Pharm Pharm Sci 2016;5:878-87.
21. Shilpa NV, Rajashree C, et al. Simultaneous quantitative estimation of netupitant and palonosetron HCl by HPTLC method development and validation. Eur J Biomed Pharm Sci 2016;3:421-6.
22. Hang TJ, Yu XR, Song M. Direct enantiomeric separation of palonosetron hydrochloride by chiral HPLC. Chin J New Drugs 2008;5:10-6.
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How to Cite
M, M. “METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTIFICATION OF NETUPITANT AND PALONOSETRON IN BULK AND PHARMACEUTICAL DOSAGE FORM AND THEIR FORCED DEGRADATION STUDY BY RP-HPLC”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 2, Jan. 2019, pp. 119-23, https://innovareacademics.in/journals/index.php/ajpcr/article/view/28949.
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