A STABILITY INDICATING UV SPECROPHOTOMETRIC METHOD FOR DETERMINATION OF METOCLOPRAMIDE HYRDROCHLORIDE
Keywords:
Metoclopramide hydrochloride, Stability indicating, UV Bulk, Forced degradationAbstract
A stability indicating method has been developed for specific determination of Metoclopramide HCl in bulk by UV spectrophotometry in presence of its degradation products. The method is simple, accurate, precise, and robust. Linearity range for the method is 10-50µg/ml at detection wavelength of 272 nm. The LOD and LOQ values were found to be 3.26µg/ml and 9.89µg/ml respectively.
Downloads
References
British Pharmacopoeia 2009.
www. drugbank. ca
Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs: a review. J Pharm Anal 2013;9:3-6.
Gaikwad S, Kondawar M, Nazarkar S, Phase S, Narkhede H. RP-HPLC method for the simultaneous determination of metoclopramide hydrochloride and paracetamol in tablet dosage form. Int J Pharm Life Sci 2010;1(3):127-32.
Nabeel SO, Hana SM, Nada AK. Spectrophotometric and High Performance Liquid Chromatographic Methods for Determination of Metoclopramide in Pharmaceutical Preparations. Rafidian J Sci 2011;22(3):39-56.
Dudhane NP, Vidhate SS, Borkar BH, Lohiya RT, Umekar MJ. Simultaneous UV Spectrophotometric estimation of Metoaclopramide hydrochloride and Paracetamol in solid dosage form. Int J Pharm Sci Res 2010;2(1):48-52.
Wamorkar V, Manjunath SY, Varma MM. Development and Validation of UV Spectroscopic Method for Determination of Metoclopramide Hydrochloride in Bulk and Tablet Formulation. Int J Pharm Pharm Sci 2011;3(3):171-4.
Aubert M, Jean-Louis HJ. LC–MS characterization of Metoclopramide photolysis products. J Photochemistry Photobiology A: Chemistry 2009;205:197–202.
Miao Y, Huen DL, Ben MC, Xiao LL, Yun GZ. Determination of Metoclopramide in human plasma by LC-ESI-MS and its application to bioequivalence study. J Chromatography B 2010;878:884-7.
Singh S, Bakshi M. Development of validated stability indicating assay methods-critical review. J Pharm Biol Anal 2002;28:1011-40.
FDA. Guidance for Industry: impurities in drug product, Draft Guidance. Center for Drug Evaluation Res 2003.
International Conference on Harmonization (ICH), Guidance for Industry, Q1A (R2): Stability Testing of New Drugs and Products. IFPMA Geneva 2003.
Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Pharm Technology 2000;24:1-14.
International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology. Q2 (R1), Nov 2005.
Kudige NP, Kanakapura B, Cijo MX, Madihalli SR. Development and validation of stability-indicating uv spectrophotometric methods for the determination of zolmitriptan in pharmaceuticals. Int J Pharm Chem Sci 2013;2(1):236-45.