Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Research Article

Simultaneous Quantification of Pantoprazole and Levosulpiride in Spiked Human Plasma Using High Performance Liquid Chromatography Tandem Mass Spectrometry

Author(s): Vulli Srinandan, Krishnaveni Nagappan*, Sonam Patel, Karthik Yamjala, Gowramma Byran and Basavan Babu

Volume 15, Issue 1, 2019

Page: [17 - 23] Pages: 7

DOI: 10.2174/1573412914666180101142646

Price: $65

Abstract

Background: Pantoprazole (PTZ) and Levosulpiride (LS) were proven as effective agents for the treatment of Gastro-Esophageal Reflux Disease (GERD). It is a complex motor disorder that results in regurgitation of the gastric contents into the lower esophagus with consequent symptoms such as heart burn, retrosternal pain, dysphagia and belching.

Methods: A rapid, sensitive, selective and specific liquid chromatography- electro spray ionization tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous quantification of Pantoprazole (PTZ) and Levosulpiride (LS) in spiked Human Plasma. The method utilized SPE as sample preparation technique and the analysis was carried out on a HPLC system utilizing electro spray ionization as interface and triple quadrupole mass analyzer for quantification in MRM possitive mode. Iloperidone was used as internal standard (IS). Chromatographic separation was performed on a Phenomenex C-18 Column (4.6 mm x 50 mm, 5µ) with an isocratic elution mode utilizing a mobile phase composition of Solution containing a mixture of 70 volumes of acetonitrile: 30 volumes of methanol and 10mM ammonium formate (pH 4.0) at the ratio of 80:20 % v/v. The flow rate was maintained at 0.3 mL/min.

Results: PTZ, LS and IS were detected and quantified with proton adducts at m/z 383.37→200.00, m/z 341.42→112.15 and 426.48→261.00 respectively. The linearity and range was established by fortifying blank plasma samples in the concentration range of 3.5-2000 ng/mL for PTZ and 3.0-2400 ng/mL for LS. The correlation coefficient (r2) was found to be ≥ 0.993 for PTZ and (r2) ≥ 0.990 for LS. The lower limit of quantification for PTZ was 3.5 ng/mL and LS was 3.0 ng/mL. The intra and inter day precision and accuracy for PTZ and LS were within the limits fulfilling the international acceptance criteria. PTZ and LS were found to be stable throughout three freeze-thaw cycles, bench top and short term stability studies.

Conclusion: The proposed validated LC-MS/MS method offers a sensitive quantification of PTZ and LS in spiked human plasma and can be utilized for the quantification of PTZ and LS in real-time samples.

Keywords: Pantoprazole, levosulpiride, bioanalytical method, validation, LC-MS/MS, benzimidazole.

Graphical Abstract
[1]
Andrew, F.; Lynda, W. Pantoprazole: A review of its pharmacological properties and therapeutic use in acid related disorders. Drugs, 1996, 51(3), 460-482.
[2]
Paul, W.J. Pantoprazole: A New proton pump indibitor. Clin. Therapeut., 2000, 22(11), 1268-1293.
[3]
Distrutti, E.; Fiorucci, S.; Hauer, S.K.; Pensi, M.O.; Vanaisa, M.; Morelli, A. Effect of acute and chronic levosulpiride administration on gastric tone and perception in functional dyspepsia. Aliment. Pharmacol. Ther., 2002, 16, 613-622.
[4]
Mucci, A.; Nolfe, G.; Maj, M. Levosulpiride: A review of its clinical use in psychiatry. Pharmacol. Res., 1995, 31(2), 95-101.
[5]
Rossi, F.; Forgione, A. Pharmaco toxicological aspects of levosulpiride. Pharmacol. Res., 1995, 31(2), 81-94.
[6]
Guslandi, M. The clinical use of levosulpiride. Curr. Ther. Res., 1993, 53(5), 484-501.
[7]
Sony, M.; Ashley, R.; Chenlu, T.; Qiang, C. An update on the use pf pantoprazole as a treatment for gastro esophageal reflux disease. Clin. Exp. Gastro., 2010, 3, 11-16.
[8]
Balasekhara, R.C.; Sai, H.S.B.; Bahlul, Z.A.; Babu, R.C.; Chandrasekhar, K.B.; Mukkanti, K. Development and validation of a sensitive bioanalytical method for the quantitative estimation of pantoprazole in human plasma samples by LC-MS/MS: Application to bioequivalence study. J. Chromatogr. B., 2010, 878, 1499-1505.
[9]
Yun, L.; Mei-Juan, D.; Jing, M.; Shu, W.; Xiao-Li, W.; Hui-Juan, X. Quantification of pantoprazole in human plasma using LC-MS/MS for pharmacokinetics and bioequivalence study. Eur. J. Drug Metab. Pharmacokinet., 2011, 35, 147-155.
[10]
Ling, J.; Wang, H.; Shentu, J.Z.H. Determination of pantoprazole in human plasma by HPLC-MS. Chi J. Mod. App. Pharm, 2005, 54(6), 306-308.
[11]
Osmair, P.; Celso, H.O.; Rafael, E.B-A.; Vinicius, M.R.; Gustavo, D.M.; de Nucci, G. Determination of pantoprazole in human plasma by LC-MS-MS using lansoprazole as internal standard. Arzneim. For. Sch. Drug Res., 2004, 54(6), 314-319.
[12]
Ramakrishna, N.V.S.; Vishwottam, K.M.; Wishu, S.; Koteshwara, M. High-performance liquid chromatography method for the quantification of pantoprazole in human plasma. J. Chromatogr. B., 2005, 822, 326-329.
[13]
Safwan, A.; Soulafa, O. A modified high-performance liquid chromatographic method for the analysis of pantoprazole sodium in pharmaceutical dosage forms using lansoprazole as internal standard. Arabian. J. Chem., 2016, 9, 114-119.
[14]
Kothapalli, L.P.; Inamdar, A.A.; Nanda, R.K.; Thomas, A.B. Development and validation of a stability indicating RP-HPLC method for the simultaneous estimation of pantoprazole sodium sesquihydrate and levosulpiride in a combined dosage form. Int. J. Res. Pharm. Sci, 2014, 4(4), 32-38.
[15]
Nicolas, P.; Fauvelle, F.; Ennachachibi, A. Improved determination of sulpiride in plasma by ion pair liquid chromatography with fluorescence detection. J. Chromatogr., 1986, 381, 393-400.
[16]
Bok, P.; Ya, M.; Hye, Y.J.; Hui-Kyun, K.; Hye, W.L.; Yong-Bok, L. Hydrophillic interaction liquid chromatography-tandem mass spectrometry for the determination of levosulpiride in human plasma. J. Chromatogr. B., 2004, 809, 345-350.
[17]
Jin-Hee, P.; Yoo-Sin, P.; Si-Youn, R.; Hyun-Jin, K.; Ok-Hwa, J.; Yun-Sik, L. Rapid quantification of levosulpiride in human plasma using RP-HPLC-MS/MS for pharmacokinetic and bioequivalence study. Biomed. Chromatogr., 2009, 23, 1350-1356.
[18]
Prasad, B.P.; Hae, W.L.; Mi-Sun, L.; Sook, J.S.; Eun-Hee, K.; Jeonghyeon, P. Liquid chromatography-tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study. J. Chromatogr. B., 2010, 878, 2280-2285.
[19]
Chunduri, R.H.B.; Dannana, G.S. Development and validation of a high throughput UPLC-MS/MS method for simultaneous quantification of esomeprazole, rabeprazole and levosulpiride in human plasma. J. Pharm. Anal., 2016, 6, 190-198.
[20]
Rakesh, D.; Pal, T.K. Method development & validation of LCMS/MS for atorvastatin and olmesartan in human plasma to trace drug interaction of formulation. Curr. Pharmaceut. Anal., 2015, 11(1), 43-52.
[21]
Draft guidance for industry: Bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research and Centre for Veterinary Medicine, September 2013..
[22]
U.S. Food and Drug Administration - Protecting and Promoting Your Health. Available from:. http://www.fda.gov/downloads/ Drugs/GuidanceComplainceRegulatoryinformation/Guidances/UCM368107.pdf
[23]
EMEA guideline on Bioanalytical Method Validation, 2011..

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy