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Development and Validation of Cost Effective UV-Spectrophotometric Method for Estimation of Domperidone in Bulk and Pharmaceutical Formulations
Corresponding Author(s) : Satish Reddi
Asian Journal of Chemistry,
Vol. 29 No. 12 (2017): Vol 29 Issue 12
Abstract
Simple and cost effective UV-spectrophotometric method was developed for the estimation of domperidone in bulk and pharmaceutical formulations. Domperidone was analyzed at 284 nm in 100 mM hydrochloric acid (pH 1.2). Apparent molar absorptivity and Sandell’s sensitivity were found to be 1.27 × 104 L mol-1 cm-1 and 0.034336 μg cm-2/0.001A, respectively which infer good sensitivity of the method. The method demonstrated linearity in concentration range of 5-35 μg mL-1 (regression equation: absorbance = 0.0289 × concentration in μg mL-1 + 0.0077; R2 = 1) in selected media. Method was fully validated for selectivity, accuracy, precision, robustness as per ICH guidelines. The detection and quantification limits were found to be 0.398 and 1.121 μg mL-1, respectively. The results of various validation parameters confirmed that the proposed method is accurate, selective and precise (relative standard deviation < 2 %), while being simple and cost effective. This method was found suitable for qualitative and quantitative estimation of domperidone in bulk and different formulation.
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References
R.D. Allan and G.A.R. Johnston, Clin. Res. Rev., 3, 91 (1983); https://doi.org/10.1002/med.2610030202.
R.N. Brogden, A.A. Carmine, R.C. Heel, T.M. Speight and G.S. Avery, Drugs, 24, 360 (1982); https://doi.org/10.2165/00003495-198224050-00002.
P.R. Kumar, P.B. Prakash, M.M. Krishna, M.S. Yadav and C.A. Deepthi, E-J. Chem., 3, 142 (2006); https://doi.org/10.1155/2006/640731.
A.H. Patel, J.K. Patel, K.N. Patel, G.C. Rajput and N.B. Rajgor, Int. J. Biol. Pharm. Res., 1, 1 (2010).
A. Shirwaikar, A. Shirwaikar, C.D. Kumar, A. Joseph, R. Kumar and S.L. Prabu, Indian J. Pharm. Sci., 70, 128 (2008); https://doi.org/10.4103/0250-474X.40351.
S.C. Reddymasu, I. Soykan and R.W. McCallum, Am. J. Gastroenterol., 102, 2036 (2007); https://doi.org/10.1111/j.1572-0241.2007.01255.x.
B.H. Patel, B.N. Suhagia, M.M. Patel and J.R. Patel, J. Chromatogr. Sci., 46, 304 (2008); https://doi.org/10.1093/chromsci/46.4.304.
K. Karunakaran, G. Navaneethan and K.P. Elango, Trop. J. Pharm. Res., 11, 99 (2012); https://doi.org/10.4314/tjpr.v11i1.13.
P.V. Rao, C.K.S. Reddy, M.R. Kumar and D.D. Rao, J. Liq. Chromatogr. Rel. Technol., 35, 2322 (2012).
S. Thanikachalam, M. Rajappan and V. Kannappan, Chromatographia, 67, 41 (2008); https://doi.org/10.1365/s10337-007-0452-y.
A. Bose, U. Bhaumik, A. Ghosh, B. Chatterjee, U.S. Chakrabarty, A.K. Sarkar and T.K. Pal, Chromatographia, 69, 1233 (2009); https://doi.org/10.1365/s10337-009-1032-0.
M.J. Smit, F.C.W. Sutherland, H.K.L. Hundt, K.J. Swart, A.F. Hundt and J. Els, J. Chromatogr. A, 949, 65 (2002); https://doi.org/10.1016/S0021-9673(01)01553-9.
USP United States pharmacopoeia, NF 26. United States Pharmacopeia Convention, Asian edition, Rockville, 31, p. 683-687 (2008).
ICH, Q2R1 Validation of Analytical Procedures: Text and Methodology; International Conference on Harmonization, Geneva (1996).
ICH, Q1A(R2), Stability Testing of New Drug Substances and Products, International conference on Harmonization. Geneva (2003).
G. Singhvi, P. Kalantare, H. Dhoot and R.N. Saha, Asian J. Chem., 25, 3682 (2013); https://doi.org/10.14233/ajchem.2013.13716.