HPLC METHOD DEVELOPMENT AND VALIDATION OF RABEPRAZOLE AND LEVOSULPIRIDE IN ITS BULK AND DOSAGE FORM
Abstract
Analytical method is heart of pharmaceutical analysis. The present work was attempted to develop accurate, simple and sensitive method for simultaneous estimation of rabeprazole and levosulpiride. The mobile phase was consisted of Buffer: Acetonitrile, with ratio of (70:30) at flow rate was quite satisfactory. In our study, the percentage recovery of LEVO was found to be 99.98%, 100.06%, & 100.1% from 80%, 100%, 120% sample solution respectively. For RABE was found to be 98.99%, 99.46%, & 100.08% from 80%, 100%, 120% sample solution respectively. The obtained percentage recovery of both drugs was found to be within the range. This indicates the proposed method was more accurate than the existing methods. Precision is determined by using the method to assay a sample for a sufficient number of times to obtain statistically valid results. The precision is then expressed as the percentage relative standard deviation. Acceptance criteria for the precision of method is that % RSD should not be more than 2%. In the present study for intermediate precision % RSD for LEVO and RABE was found to be 0.344, 0.242 respectively. % RSD value indicate a good degree of precision within specified range.
Keywords:
HPLC, Rabeprazole, Levosulpiride, Simultaneous, Method developmentDOI
https://doi.org/10.25004/IJPSDR.2022.140403References
Grasselli J. The Analytical Approach, American Chemical Society, Washington, DC, 1983.
Sigga S. Survey of Analytical Chemistry, McGraw-Hill, New York, 1968.
Sharma BK. Instrumental Methods of Analysis. 16th ed, Goel Publishing House, Meerat.
Skoog, Holler, Nieman. Molecular Spectroscopy. In: Principles of instrumental analysis. 5th ed. Singapore: Thomson Asia Pte. Ltd, 2004, 342-344.
Sethi PD. Quantitative analysis of Drugs in pharmaceutical formulation. 2nd ed, 33- 41.
Backett AH, Stenlake JB. Practical pharmaceutical chemistry, 4th ed. 2004; (2):1-2.
Validation of Compendial Methods, USP29, 3050-3053S.
Bakshi SM. Understanding Analytical Method Validation. Pharma. Times, 1999: 15-20.
ICH Guidance on Analytical Method Validation, International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, 2002.
William Kemp, Organic Spectroscopy, ELBS, 243.
Skoog, Douglas A, Holler FJ, Crouch, Stanley R. Principles of Instrumental Analysis. Belmont, CA: Brooks/Cole, Thomson. 2007: 1-13.
Deulgaonkar YB, Patel JA, Mahajan MP, Sawant SD. A simple and validated rp-hplc method for the simultaneous estimation of levosulpiride and rabeprazole sodium in bulk and pharmaceutical dosage forms. Indo American Journal of Pharmaceutical Research, 2016; 6(7): 4017-4025.
Rambabu C, Challa S, Rao BT. Method development and validation for simultaneous estimation of rabeprazole and levosulpiride in bulk and pharmaceutical dosage forms. World Journal of Pharmaceutical Sciences, 2015: 2321-3310.
Surve S, Patwari A, Patel JA, Rathod I, Chhabria M. Hptlc and hplc method development and validation for simultaneous estimation of rabeprazole sodium and levosulpiride in bulk and its pharmaceutical dosage form. International journal of Pharmacy and Pharmaceutical Sciences, 2013; 5(3):65-69.
Shilpa S, Annapurneswari TS, Rao VJ, Rajesh B, Venkateshwarao PB, China R. Simultaneous Estimation and Validation of Levosulpiride and Rabeprazole Sodium in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method. Journal of pharmacy research, 2012; 5(10): 5010-5013.
Sirisha A, Kumar RA. Method development and validation of simultaneous estimation of levosulpiride and rabeprazole in bulk and pharmaceutical dosage form by RP-HPLC. International Research Journal of Pharmaceutical and Applied Sciences, 2012;2(4): 49-55.
Published

