Development and Validation of New Analytical Method for The Simultaneous Estimation of Netupitant And Palonosetron In Pharmaceutical Dosage Form
Abstract
A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in Pharmaceutical dosage form. The chromatogram was run through Std Discovery C18250 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA (2.2ph): Acetonitrile taken in the ratio 55:45 was pumped through the column at a flow rate of 1 ml/min. The buffer used in this method was 0.1% OPA. The temperature was maintained at 30°C. The optimized wavelength selected was 220 nm. The retention time of Netupitant and Palonosetron was found to be 2.308min and 3.093min. %RSD of the Netupitant and Palonosetron were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 99.51% and 99.29% for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.84, 0.01, and 5.59, 0.03 respectively. Regression equation of Netupitant is y = 7232.8x + 3439.3., and y = 28857x + 97.732 of Palonosetron. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.
Keywords:
Netupitant, Palonosetron, RP-HPLC
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References
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Pemra Raju, K. Thejomoorthy, and P.Sreenivasa Prasanna, “Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form”, Int J Indig Herb Drug, pp. 49-57, Apr. 2021.
P, S. P., T. K, and D. B. P. “HPLC Method Development And Validation For The Simultaneous Estimation Of Levocetirizine And Phenylephrine In Bulk And Pharmaceutical Dosage Form”. International Journal of Pharmacognosy and Chemistry, June 2020, pp. 19-30.
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.
Paula G, Axel G, Loprinzi CL. Nausea and Vomiting in the Cancer Patient. New York: Springer; 2006. p. 1482-96.
Judith ET. Emergency Medicine: A Comprehensive Study Guide. New York: McGraw-Hill Companies; 2010. p. 830.
Corrie PG, Pippa G. Cytotoxic chemotherapy clinical aspects. Medicines 2008;36:24-8.
Levi JA, Aroney RS, Dalley DN. Haemolytic anaemia after cisplatin treatment. Br Med J (Clin Res Ed) 1981;282:2003-4.
Barnes NM, Hales TG, Lummis SC, Peters JA. The 5-HT3 receptor-the relationship between structure and function. Neuropharmacology 2009;56:273-84.
Purves D, Augustine GJ, Fitzpatrick D. Neuroscience. 4th ed. Sunderland (MA): Sinauer Associates; 2008. p. 11-20.
Berthoud HR, Neuhuber WL. Functional and chemical anatomy of the afferent vagal system. Auton Neurosci 2000;85:1-7.
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.
Lutz DS Dictonary of Minor Planet Names-Posterma. Berlin Heidelberg: Springer; 2007. p. 118.
Pietra S. Indolic derivatives II. A new way to synthesize serotonin. Farmaco Sci 1958;13:75-9.
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.
Pathi PJ, Raju NA The estimation of palonosetron hydrochloride in parenterals by RP-HPLC. Asian J Pharm Tech 2012;2:77-9.
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.
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.
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.
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.
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.
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.
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.
Hang TJ, Yu XR, Song M. Direct enantiomeric separation of palonosetron hydrochloride by chiral HPLC. Chin J New Drugs 2008;5:10-6.
Rao CP, Rahaman SA, Prasad YR, Reddy PG. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. International Journal of Pharmaceutical Research and Development. 2010 Nov;2(9):69-76.
Rao CM, Konda R, Ramanjeneeyulu S. Estimation of Nevirapine Anhydrous Bulk Formulation by Using IR, RP-HPLC, GC Methods. Research Journal of Pharmacy and Technology. 2010 Dec 28;3(4):1088-92.
Ch M M Prasada et al, Development and Validation of a Novel Stability Indicating RP-HPLC Method for The Estimation of Entecavir In Tablet Formulation, EJBPS, 2017, 4(7):176-180
Kumaraswamy.Gandla, R.Lalitha, Dara Varun Kumar, and P.VR Teja Shruthi. “Analytical Method Development & Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and it’s Dosage Form by Rp-Hplc”. International Journal of Pharmaceutics and Drug Analysis, Apr. 2020, pp. 6-15,
Gokul S. Sanap, Nilesh S. Zarekar, and Sarita S. Pawar. “REVIEW ON METHOD DEVELOPMENT AND VALIDATION”. International Journal of Pharmaceutics and Drug Analysis, May 2017, pp. 177-84.
Z. M. Sayyed, Aijaz A. Sheikh, Zakirhussain A. Shaikh, S. A. Shinde, . J. Chaware5, and K. R. Biyani. “DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF TENO-FOVIR AND EMTRICITABINE IN PHARMACEUTICAL DOSAGE FORMS BY HPLC”. International Journal of Pharmaceutics and Drug Analysis, Jan. 2016, pp. 24-29.
K, V. G., T. K, and S. P. P. “A New Stability Indicating Analytical Method Development And Validation for The Quantitative Determination of Emitricitabine And Lamivudine By RP-HPLC”. World Journal of Current Medical and Pharmaceutical Research, Vol. 2, no. 2, May 2020, pp. 184-90, doi:10.37022/WJCMPR.2020.2219.
Pemra Raju, K. Thejomoorthy, and P.Sreenivasa Prasanna, “Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form”, Int J Indig Herb Drug, pp. 49-57, Apr. 2021.
P, S. P., T. K, and D. B. P. “HPLC Method Development And Validation For The Simultaneous Estimation Of Levocetirizine And Phenylephrine In Bulk And Pharmaceutical Dosage Form”. International Journal of Pharmacognosy and Chemistry, June 2020, pp. 19-30.
Published
13/05/2021
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Potluri Surendra, P.Sreenivasa Prasanna, and K. Thejomoorthy. “Development and Validation of New Analytical Method for The Simultaneous Estimation of Netupitant And Palonosetron In Pharmaceutical Dosage Form”. International Journal of Pharmacognosy and Chemistry, Vol. 2, no. 2, May 2021, pp. 50-59, doi:10.46796/ijpc.vi.158.
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