Development of a Spectrophotometric Method for the Quantitative Estimation of Zidovudine Concentration in Bulk and Pharmaceutical Dosage Forms
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Abstract
A simple, accurate, precise, sensitive and a highly selective spectrophotometric method was developed and validated for the estimation of Zidovudine in bulk and pharmaceutical dosage forms. The stock solutions were prepared as per procedure and were scanned at maximum absorbance of 266 nm. The linearity was found in the concentration range of 2-20 µg / mL. The Coefficient of determination (r2) was 0.999. The regression equation was found to be Y = 0.0435. C + 0.0205 and % RSD was found to be 0.630. The developed method was validated according to ICH guidelines and was found to be accurate and precise. The validation parameters are linearity, accuracy, precision, limit of detection, limit of quantitation, robustness and ruggedness. Thus the proposed method can be successfully applied for the estimation of Zidovudine in bulk and pharmaceutical dosage forms.
Keywords: Zidovudine, Validation, ICH guidelines, Spectrophotometric method
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E-mail: chejetisharadha@gmail.com
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References
[2] http://en.wikipedia.org/wiki/Zidovudine
[3] Cimons, Marlene. 1987. U.S. Approves Sale of AZT to AIDS Patients. Los Angeles Times: p. 1.
[4] United States Pharmacopoeia (USP-NF XXIV), 1985. Rockville MD 20852. United States Pharmacopoeial Convention Inc, p. 3489.
[5] Bengi Uslu and Sibel A Ozkan, 2002. Determination of Lamivudine and Zidovudine in binary mixtures using First Derivative Spectrophotometric, first derivative of the ratio-spectra and HPLC-UV methods, Analytical Chemica Acta, 466 (1), 175-185.
[6] K. Basavaiah and UR. Anil Kumar, 2006. Simple Spectrophotometric methods for the determination of Zidovudine in pharmaceuticals using Chloramine-T, Methylene Blue and Rhodamine-B reagents, E-Journal of Chemistry. 3 (12), 173-181.
[7] N. Hari krishanan, 2008. Simultaneous estimation of Lamivudine, Zidovudine and Nevirapine by R. P. HPLC in pure and pharmaceutical dosage form, Asian Journal of Chemistry, 20 (4), 2551-2556.
[8] Arlene S. Pereira, Kathryn B. Kenney, Myron S. Cohen, James E. Hall, Joseph J. Eron, Richard R. Tidwell and John A. Dunn, 2000. Simultaneous determination of Lamivudine and Zidovudine concentrations in human seminal plasma using High Performance Liquid Chromatography and Tandem Mass spectrometry, Journal of Chromatography B, 742 (1), 173-183.
[9] Emilia Marchei, Luisa Valvo, Roberta Pacifici, Manuela Pellegrini, Gianna Tossini and Piergiorgio Zuccaro, 2002. Simultaneous determination of Zidovudine and Nevirapine in human plasma by Reverse Phase-Liquid Chromatography, Journal of Pharmaceutical Biomedical Analysis, 29 (6), 1081-1088.
[10] Bin Fan and James T Stewart, 2002. Determination of Zidovudine / Lamivudine / Nevirapine in human plasma using ion-pair High Performance Liquid Chromatography. Journal of Pharmaceutical Biomedical Analysis, 28 (5), 903-908.
[11] Geetha Ramachandran, A. K. Hemanthkumar, V. Kumaraswami and Soumya Swaminathan,2006. A simple and rapid Chromatographic method for simultaneous determination of Zidovudine and Nevirapine in plasma. Journal of Chromatography B. 843 (2), 339-344.
[12] Ashenafi Dunge, Nishi Sharda, Baljinder Singh and Saranjit Singh. 2005. Validated specific High Performance Liquid Chromatography method for determination of Zidovudine during stability studies. Journal of Pharmaceutica Bio Anal, 37 (5), 1109-1114.
[13] Girum and Habte, 2001. Simultaneous determination of Lamivudine and Zidovudine in pharmaceutical formulations by High Performance Thin Layer chromatography (HPTLC) - Densitometric method. Journal of Chromatography B, 782 (1), 130-141.
[14] Neeraj Kaul, 2004. Stability indicating HPTLC determination of Zidovudine as the bulk drug and in pharmaceutical dosage form. Journal of Planar Chromatography-Modern TLC, 17 (1), 264-274.
[15] Robert A Nash and Alfred H Wachter. Pharmaceutical Process Validation, James Swarbrick, North Carolina, An international 3rd ed, Revised and Expanded, Vol. 129, Marcel Dekker, Inc., New York, 507-522.
[16] International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human use. 1996. Validation of Analyticalprocedures: Methodology. ICHQ2B, Geneva, (CPMP/ICH/281/95).
[17] I. C. H. 1996. Harmonized Tripartite guideline. Recommended for adaptation at step-4 of the ICH process, By ICH steering committee.
[18] Green J. M. 1996 (May 1). A practical guide to analytical method validation, Anal Chem. News Feat 305A/309A