Rapid Validated Stability Indicating Method for Nizatidine and Its Impurities Quantification

Antony Raj  Gomes; Pannala  Raghuram; J.  Sriramulu; Nimmakalaya  Srinivas

doi:10.4236/ajac.2011.23039

Antony Raj Gomes, Pannala Raghuram, J. Sriramulu, Nimmakalaya Srinivas

Abstract: This research article describes stability indicating fast liquid chromatographic method for determination of chromatographic purity and assay of Nizatidine as a alternate for two different methods for chromatographic purity and assay as given in USP Monograph and Ph.Eur Monograph. Proposed method is developed on Waters symmetry RP18 (50 × 4.6 mm), 3.5 μm stationary phase using gradient elution with combination of Ammonium acetate Diethyl amine buffer, Methanol and Tetrahydrofuran as mobile phase. Favorable results are obtained under developed conditions, which guarantee good separation of studied components. Whereas, data obtained from method validation confirm specificity, high sensitivity, linearity in a range of studied concentrations, repeatability and good accuracy of this method. Considerable degradation observed in oxidation stress condition was detected by this method. Eight impurities are studied among which impurity-5 is found major degradant. The stress samples are assayed against a qualified standard and the mass balance is found close to 99.2%. The developed method can be used for routine samples as well as stability studies.

Keywords: Column Liquid Chromatography, Nizatidine, Forced Degradation, Validation; Stability Indicating

Cite this paper: nullA. Gomes, P. Raghuram, J. Sriramulu and N. Srinivas, "Rapid Validated Stability Indicating Method for Nizatidine and Its Impurities Quantification," American Journal of Analytical Chemistry, Vol. 2 No. 3, 2011, pp. 314-323. doi: 10.4236/ajac.2011.23039.

References

[1] M. Atmaca, M. Kuloglu, E. Tezcan, B. Ustundag and N. Kilic, “Nizatidine for the Treatment of Patients with Quetiapine-Induced Weight Gain,” Hum Psychopharmacol, Vol. 19, No. 1, 2004, pp. 37-40. doi:10.1002/hup.477

[2] PRNewswire, “Eli Lilly and Company and Reliant Pharmaceuticals Announce Agreement for U.S. Sales and Marketing Rights to Axid (R),” Indianapolis, September 7, 2000.

[3] F. Parente and G. B. Porro, “Acid Inhibitory Characteristics of Nizatidine in Man: An Overview,” Scandinavian Journal of Gastroenterology, Vol. 29, No. s206, 1994, pp. 3-7. doi:10.3109/00365529409091413

[4] The United States Pharmacopoeia 32 National Formulary 27. (USP)

[5] European Pharmacopoeia 4.2, Council of Europe, 2002, pp. 2737-2739.

[6] U. D. Neue, D. McCabe, V. Ramesh, H. Pappa, J. DeMuth, “Transfer of HPLC Procedures to Suitable Columns of Reduced Dimensions and Particle Sizes,” Pharmacopeial Forum, Vol. 35, No. 6, 2009, pp.1622-1626.

[7] International Conference on Harmonization (ICH), “Stability Testing of New Drug Substances and Products,” ICH Topic Q1A (R2), ICH Secretariat, Geneva, 2005.

[8] International Conference on Harmonization (ICH), “Photostability Testing of New Drug Substances and Products,” ICH Q1B Guidline, ICH Secretariat, Geneva, 2005.

[9] S. W. Baertschi, K. Alsante and R. A. Reed, “Pharmaceutical Stress Testing: Predicting Drug Degradation,” Drugs and the Pharmaceutical Sciences, Vol. 153, 2005, pp. 1-482. doi:10.1201/9780849359194.ch3

[10] US FDA guidance, “Analytical Procedures and Methods Validation,” Food and Drug Administration, Rockville, 2000.

[11] The United States Pharmacopeial Convention, “Validation of Compendial Methods <1225>,” The United States Pharmacopeia, Rockville, 2009.

[12] M. E. Swartz and I. S. Krull, “Developing and Validating Stability-Indicating Methods by Michael Swartz and Ira Krull,” LC-GC North America, 2005.

[13] International Conference on Harmonization (ICH), “Validation of Analytical Procedures: Text and Methodology,” Q2 (R1), ICH Secretariat, Geneva, 2005.

[14] J. Ermer and J. H. McB. Miller, “Method Validation in Pharmaceutical Analysis: A Guide to Best Practice,” Wiley-VCH, enero, 2005.

[15] D. M. Bliesner, “Validating Chromatographic Methods: A Practical Guide,” Wiley, Hoboken, 2006, pp.1-304.