Analytical method development and validation studies for the estimation of H2 receptor antagonist drug (Ranitidine)
DOI:
https://doi.org/10.18203/issn.2454-2156.IntJSciRep20210091Keywords:
Ammonium acetate, Methanol, Ranitidine, RP-HPLC, UVAbstract
Background: An analytical science in the development, finding a new molecules and procreation of pharmaceuticals has been an extensive approached. From the evaluation over small quantities of complex biological substances to the quality monitoring of the finished dosage form, the use on analytical technology know- how covers an ample thoroughness over techniques or disciplines.
Methods: Reversed phase high performance liquid chromatography (RP-HPLC) approach has been promoted for the discernment over Ranitidine (RAN) within pharmaceutical dosage form split of RAN was accomplished inside a unaccompanied chromatographic run of an Phenomenix column size 5 μm 4.6x250 mm along with UV analysis at 227 nm wavelength, below isocratic conditions, using Ammonium acetate and Methanol (pH 6.0) in 80:20 ratio. Validation parameters had been observed in accordance with exhibit linearity, accuracy, precision, Limit of Quantitation and Limit of detection in conformity in imitation of ICH guidelines.
Results: The contemporary approached demonstrates significant linearity upon the range concerning 50-202.5 μg/ml for RAN followed by intra-day and inter-day precision, expressed so the relative standard deviation (RSD), on replicates is <2.0 and accuracy among the range over 98-102%.
Conclusions: The flourished RP-HPLC technique was once innovative, suitable for detecting RAN in pure form and in pharmaceutical preparation.
Metrics
References
David CL, Michael L. Webb. Pharmaceutical Analysis. 1st Ed. Black well publishing. 1994:2-4.
Day RA, Underwood AL. Quantitative Analysis. 4th Ed. New Delhi: Prentice Hall. 1986.
Michael E, Schartz IS, Krull. Analytical method development and Validation. 3rd Ed. London: John Wiley & sons 2004;25-46.
Kazakevich Y, Lobrutto R. HPLC for Pharmaceutical Scientist. 4th Ed. New York Wiley & Sons Inc. 2007.
Lindsay S. High Performance Liquid Chromatography.1st ed. London: John Wiley & Sons. 1991:45-75.
Lough WJ, Wainer IW. High Performance Liquid Chromatography Fundamental Principles & practice Glasgow (UK): Blackie Academic & Professional 1995;2-28.
Snyder LR, Kirkland JJ, Joseph LG. Practical HPLC Method Development. 2nd Ed. New York: Wiley and sons. 1997:46-51.
Sharma N, Rao SS, Durga N, and Reddy PS. Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine HCL in Liquid Oral Dosage Form. Sci Pharm. 2011;79(2):309-22.
Asian Guideline for Validation of Analytical Procedure Adopted from ICH guideline, Q2A27 and ICH Q2B. 1994.
International Conference on Harmonization,"Q2B. Validation of Analytical Procedures Methodology Availability," Federal Register. 1997;62(96):263-7.
ICH guidelines Q1A (R2). Stability Testing of New Drug Substances and Products (revision 2). 2003.
Sharma MC, Sharma S. Forced Degradation Studies and Micellar Liquid Chromatographic Method Development for Determination of Ranitidine HCL in Tablet Dosage form. Int J Chem Tech Res. 2011;3(1):199-202.
Tatar Ulu S, Tuncel M. A Sensitive and Rapid Determination of Ranitidine in Human Plasma by HPLC with Fluorescence Detection and its Application for Pharmacokinetic Study. J Chromat Sci. 2012; 50: 301–6.
Sahoo BK, Mishra AK, Pal TK. Optimization and Validation of Modulated Release Formulation of Ranitidine HCL by Response Surface Methodology. IJPSDR. 2011;3(1):13-18.
