UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RISEDRONATE IN FORMULATION
Abstract
Rapid and sensitive Ultra performance liquid chromatography method was developed and validated for quantification of Risedronate in pharmaceutical formulation. The analysis is resolved by using symmetry C18, (100 × 2.1 mm), 1.7µm column; make BEH, in an Isocratic mode, with mobile phase containing Methanol and Water in the ratio of 70:30 v/v was used. The flow rate was 0.8 ml/min and the analyte was monitored at 273 nm by UV detection. The retention time for Risedronate sodium was 2.29 mints. The method was validated for system suitability, linearity (correlation coefficient 0.999), precision, accuracy (recovery studies 98percent-102percent), specificity, ruggedness, robustness, LOD (2.98µg/ml) and LOQ (9.94µg/ml). This present method is simple, highly sensitive, precise and accurate and has the potential of being useful for routine quality control.
Key Words: Risedronate; UPLC; Validation
Downloads
References
http://www.drugbank.ca/drugs/DB00884#properties.
http://www.fda.gov/downloads/UCM270961.pdf.
Russell RG, Xia Z, Dunford JE, Oppermann U, Kwaasi A, Hulley PA, Kavanagh KL, Triffitt JT, Lundy MW, Phipps RJ, Barnett BL, Coxon FP, Rogers MJ, Watts NB, Ebetino FH: Bisphosphonates: an update on mechanisms of action and how these relate to clinical efficacy. Ann N Y Acad Sci. 2007 Nov; 1117:209-57. Pubmed.
www.mhra.gov.uk/home/groups/par/documents/con100230.pdf.
Coxon FP, Ebetino FH, Mules EH, Seabra MC, McKenna CE, Rogers MJ: Phosphonocarboxylate inhibitors of Rabgeranylgeranyltransferase disrupt the prenylation and membrane localization of Rab proteins in osteoclasts in vitro and in vivo. Bone. 2005 Sep; 37(3):349-58. Pubmed.
Development of an ion-pair reversed-phase HPLC method with indirect UV detection for determination of phosphates and phosphites as impurities in sodium Risedronate. Skopje, Macedonia. kami@ff.ukim.edu.mk
Development and validation of a micellar high-performance liquid chromatographic method for determination of risedronate in raw material and in a pharmaceutical formulation: application to stability studies. Walash M
Stability indicating ion-pair HPLC method for the determination of risedronate in a commercial formulation, ALUOCH, DR. AUSTIN OCHIENG , Journal of Liquid Chromatography and Related Technologies, 27(17), 2799-2813 (2004)http://profiles.uonbi.ac.ke/ochieng/publications/stability-indicating-ion-pair-hplc-method-determination-risedronate-commercial
IP-HPLC of Risedronate By: Jacinth A. M. McKenzie, Chemfiles Volume 5 Article 5, Senior R&D Scientist, Supelco…jmckenzie@sial.com
Thermo: Simple, Rugged, and Accurate New Method for the Assay of Risedronate in Drugs SUNNYVALE, Calif. (Nov 2011) — Thermo Fisher Scientific Inc.
GlajchL, Kirkaland J and Snyder R, Practical HPLC Method Development, edition-2nd, John Wiley and sons, INC, New York, 1999, pp: 234-260.
Michael E., Schartz S., krull, Analytical Method Development and Validation, 2004, 25-26.
Yuri Kazakevich, Rosario, Labrutto, HPLC for Pharmaceutical scientists, Blackwell publishing Ltd., 2003, pageNo: 774-796.
The International Conference on Harmonization (ICH)-Validation of analytical procedures, Methodology(Q2B), Food and Drug Administration,USA,Nov.1996.
Michael E., Schartz S., krull, Analytical Method Development and Validation, 2004, 241-257.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.