Development and Validation of a stability indicating method for the simultaneous determination of Levosulpiride and Rabeprazole by High Performance Liquid Chromatography

Authors

  • Atulita Mullapudi Pharmaceutical Research & Development Laboratory, Corpuscle Research Solutions, Visakhapatnam-530003, India.
  • Sirisha Pingali Pharmaceutical Research & Development Laboratory, Corpuscle Research Solutions, Visakhapatnam-530003, India.
  • Tata Santosh Pharmaceutical Research & Development Laboratory, Corpuscle Research Solutions, Visakhapatnam-530003, India.

Keywords:

Levosulpiride, Rabeprazole, HPLC, Proton Pump Inhibitors, Dopaminergic antagonist

Abstract

A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Levosulpiride and Rabeprazole in pharmaceutical Tablet dosage form. The mobile phase consisted of 60:40 % (v/v) of Methanol & 0.1% v/v orthophosphoric acid operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic separation of Levosulpiride and Rabeprazole was performed on AGILENT POLARIS C18 column (150 X 4.6 mm id, ODS 2, 5?m). The wavelength of detection is 232 nm. The injection volume is 20?L. The retention time of Levosulpiride and Rabeprazole are 2.1 ± 0.10 minutes and 4.1 ± 0.10 respectively. The run time of analysis is 6 minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The influence of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs was studied. Results indicated complete degradation in alkaline medium for Levosulpiride and Rabeprazole. The proposed method has been successfully used for the estimation in tablet dosage forms.

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References

Mucci A, Nolfe G and Maj M: Levosulpiride A review of its clinical use in psychiatry.Pharmacology and Respiratory 1995; 31: 95-101.

Sabnis SS, Dhavale ND, Jadhav VY, Gandhi SV, Spectrophotometric simultaneous determination of Rabeprazole Sodium and Itopride Hydrochloride incapsule dosage form. Spectrochimica Acta, 2008;69: 849-852.

Tonini M, Cipollina L, Poluzzi E, Crema F, Corazza G and De Ponti F: Clinical implications of enteric and central D2 receptor blockade by antidopaminergic gastrointestinal prokinetics. Aliment Pharmacology and Therapeutics 2004; 19:379-90.

Lozano R, Peralta Concha M, Montealegre A, deLeon A, Ortiz Villalba J and Esteban H:Effectiveness and safety of Levosulpiride in the treatment of dysmotility-like functional dyspepsia.Therapeutics and Clinical Risk Management 2007;3: 149-155.

The Martindale 35th ed: The complete drug reference, published pharmaceutical press, lambeta high street, londan SEI 75M, UK. 2006.

Rena S, Park M, Sah H, and Lee B, Effect of pharmaceutical excipients on aqueous stability of rabeprazole sodium. International J. Pharmaceutics,2008; 350: 197-204.

Ramakrishna NVS, Vishwottam KN, Wishu S,Koteshwara M, Suresh Kumar S, High performance liquid chromatography method for the quantification of rabeprazole in human plasma using solidphase extraction. J. of Chromatography B,2005; 816: 209-214.

Venkatesh chouhan*, Shobha manjunath,S.Sandeep, Spectrophotometric estimation of levosulpiride in bulk drug and formulations, Int J Pharm Pharm Sci, Vol 3, Issue 2, 2011, 135-137.

Yogesh P. Agrawal, Surya Prakash Gautam, Ajay Verma, Mona Y. Agrawal and Arun K. Gupta,Simultaneous estimation of esomeprazole and levosulpiride in solid dosage form, Pelagia Research Library Der Pharmacia Sinica, 2012, 3 (3):337-342.

S.P. Silambarasan, K. Anandakumar, R.Venkatalakshmi and C. Sasikala, evelopment of UV Spectrophotometry and RP-HPLC Methods for the Estimation of Levosulpiride in Bulk and in Tablet Formulation Asian J. Research Chem. 3(3):July- Sept. 2010, 542-544.

Snehalatha.t*, Padmalatha.m, Ramya.s,Kanakadurga.m, A simple and validated rp-hplc method for the simultaneous estimation of rabeprazole and Levosulpiride in bulk and pharmaceutical dosage forms, int. res j pharm. App sci., 2012; 2(2):99-106.

N.B. Dobaria, N. H. Vadia and S. J. Rajput,Simultaneous Spectrophotometric Estimation of Rabeprazole Sodium and Domperidone Maleate in their Combined Pharmaceutical Dosage Form, International Journal of Chem Tech Research, Vol.1, No.4, pg.no-1162-1166, Oct-Dec 2009.

Patel Vandana. B.*, Baldha R. G, and Mayank Bapna, Simultaneous Spectrophotometric Estimation of Rabeprazole Sodium and Domperidone in combined dosage forms,International Journal of PharmTech Research,Vol.2, No.2, pp 1563-1568, April-June 2010.

Janhavi R Rao*, Vishal V Bharekar, Toufik S Mulla, Savita S Yadav, and milind P Raj,validated hptlc method for simultaneous estimation of rabeprazole sodium and aceclofenac in bulk drug and formulation,international journal of comprehensive pharmacy 2011, 5 (06).

Mallikarjuna rao.N*, Development and Validation of Stability Indicating HPTLC method for Simultaneous Estimation of Paracetamol, Aceclofenac and Rabeprazole in Combined Tablet Dosage Formulation, International Journal of PharmTech Research, Vol. 3, No.2, pp 909-918, April-June 2011.

Prasanna Reddy Battu* and MS Reddy,Development and Validation of RP-HPLC for

the Rabeprazole sodium in Pharmaceutical formulations and Human Plasma, Asian J.

Research Chem. 2(1):49-51, Jan.-March, 2009.17. Vaithiyanathan Sree Janardhanan*, Rajappan

Manavalan and Kannappan Valliappan,Stability-indicating HPLC method for the simultaneous determination of pantoprazole, rabeprazole, lansoprazole and domperidone from their combination dosage forms, Int. J.Drug Dev. & Res.,Oct-Dec 2011, 3 (4): 323-335.

Published

2013-10-31
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How to Cite

Atulita Mullapudi, A. M., S. P. Sirisha Pingali, and T. S. Tata Santosh. “Development and Validation of a Stability Indicating Method for the Simultaneous Determination of Levosulpiride and Rabeprazole by High Performance Liquid Chromatography”. International Journal of Pharmaceutics and Drug Analysis, vol. 1, no. 1, Oct. 2013, pp. 25-36, https://ijpda.com/index.php/journal/article/view/1.

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