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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Minoxidil and Aminexil in Topical Formulation
Corresponding Author(s) : M. Rudrapal
Asian Journal of Chemistry,
Vol. 28 No. 1 (2016): Vol 28 Issue 1
Abstract
A RP-HPLC method was developed and validated for simultaneous determination of minoxidil and aminexil in a combined topical liquid formulation. Isocratic separation was achieved on a C18 column (250 mm × 4.6 mm i.d., particle size 5 μm, ThermoHypersil BDS) using a mobile phase consisting of methanol-phosphate buffer (pH 3.0, 60:40, v/v) at a flow rate of 1 mL/min and UV detection at 250 nm. Linearity was observed over the concentration range of 1.0-2.0 mg/mL for both minoxidil (r2 = 0.99) and aminexil (r2 = 0.99). The average percentage recovery of the method was 101.0 % with a relative standard deviation of 0.14 %. The limits of detection (LODs) were 0.7346 μg/mL and 0.2423 μg/mL for minoxidil and aminexil and limits of quantification (LOQs) were 0.7346 μg/mL and 0.2423 μg/mL, respectively. The method was validated as per ICH guidelines.
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- H.K. Gaidhane, J.P. Bidada, A.S. Bhusari, J. Pharm. Res., 4, 4481 (2011).
- A.G. Messenger and J. Rundegren, Br. J. Dermatol., 150, 186 (2004); doi:10.1111/j.1365-2133.2004.05785.x.
- Martindale, The Complete Drug Reference, Pharmaceutical Press, London, UK, edn 36, pp. 1342-1343 (2009).
- V. Pfaffen and P.I. Ortiz, Anal. Sci., 22, 91 (2006); doi:10.2116/analsci.22.91.
- O. Asmus, J.B. Landis, M.E. Grant and H.A. Havel, J. Pharm. Sci., 73, 1290 (1984); doi:10.1002/jps.2600730926.
- A. Zarghi, S.M. Shafaati, A. Foroutan and A. Khoddam, J. Pharm. Biomed. Anal., 36, 377 (2004); doi:10.1016/j.jpba.2004.06.007.
- G. Carrum, D.R. Abernethy, M. Sadhukhan and C.E. Wright III, J. Chromatogr. A, 381, 127 (1986); doi:10.1016/S0378-4347(00)83571-9.
- M.H. Golden and P.H. Zoutendam, J. Pharm. Biomed. Anal., 5, 543 (1987); doi:10.1016/0731-7085(87)80065-1.
- L. Amankwa, L.G. Chatten and S. Pons, Analyst, 108, 1221 (1983); doi:10.1039/an9830801221.
- M.E. Royer, H. Ko, T.J. Gilbertson, J.M. McCall, K.T. Johnston and R. Stryd, J. Pharm. Sci., 66, 1266 (1977); doi:10.1002/jps.2600660915.
- M. Green, A Practical Guide to Analytical Method Validation, Analytical Chemistry News and Features, May 1, p. 309A (1996).
- L. Huber, Validation of Analytical Methods, in: Validation and Qualification in the Analytical Laboratories, Interpharm Press, Buffalo Grove, IL, p. 107 (1998).
- ICH, Text on Validation of Analytical Procedures, in: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Geneva, July 2000.
- ICH, Validation of Analytical Procedure: Methodology, in: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Geneva, July 2000.
References
H.K. Gaidhane, J.P. Bidada, A.S. Bhusari, J. Pharm. Res., 4, 4481 (2011).
A.G. Messenger and J. Rundegren, Br. J. Dermatol., 150, 186 (2004); doi:10.1111/j.1365-2133.2004.05785.x.
Martindale, The Complete Drug Reference, Pharmaceutical Press, London, UK, edn 36, pp. 1342-1343 (2009).
V. Pfaffen and P.I. Ortiz, Anal. Sci., 22, 91 (2006); doi:10.2116/analsci.22.91.
O. Asmus, J.B. Landis, M.E. Grant and H.A. Havel, J. Pharm. Sci., 73, 1290 (1984); doi:10.1002/jps.2600730926.
A. Zarghi, S.M. Shafaati, A. Foroutan and A. Khoddam, J. Pharm. Biomed. Anal., 36, 377 (2004); doi:10.1016/j.jpba.2004.06.007.
G. Carrum, D.R. Abernethy, M. Sadhukhan and C.E. Wright III, J. Chromatogr. A, 381, 127 (1986); doi:10.1016/S0378-4347(00)83571-9.
M.H. Golden and P.H. Zoutendam, J. Pharm. Biomed. Anal., 5, 543 (1987); doi:10.1016/0731-7085(87)80065-1.
L. Amankwa, L.G. Chatten and S. Pons, Analyst, 108, 1221 (1983); doi:10.1039/an9830801221.
M.E. Royer, H. Ko, T.J. Gilbertson, J.M. McCall, K.T. Johnston and R. Stryd, J. Pharm. Sci., 66, 1266 (1977); doi:10.1002/jps.2600660915.
M. Green, A Practical Guide to Analytical Method Validation, Analytical Chemistry News and Features, May 1, p. 309A (1996).
L. Huber, Validation of Analytical Methods, in: Validation and Qualification in the Analytical Laboratories, Interpharm Press, Buffalo Grove, IL, p. 107 (1998).
ICH, Text on Validation of Analytical Procedures, in: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Geneva, July 2000.
ICH, Validation of Analytical Procedure: Methodology, in: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Geneva, July 2000.