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ISRN Analytical Chemistry
Volume 2013 (2013), Article ID 342794, 9 pages
Stability-Indicating Validated Novel RP-HPLC Method for Simultaneous Estimation of Methylparaben, Ketoconazole, and Mometasone Furoate in Topical Pharmaceutical Dosage Formulation
1Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Andhra Pradesh, Hyderabad 500090, India
2Department of Chemistry, National Institute of Technology, West Bengal, Durgapur 713209, India
Received 3 June 2013; Accepted 7 July 2013
Academic Editors: T. Macko, M. Özgür, and I. Zhukov
Copyright © 2013 Chinmoy Roy and Jitamanyu Chakrabarty. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
- K. Srinivasarao, V. Gorule, R. C. Venkata, and K. A. Venkata, “A validated method development for estimation of formoterol fumarate and mometasone furoate in metered dose inhalation form HPLC,” Journal of Analytical Bioanalytical Techniques, vol. 3, no. 7, pp. 1–4, 2012.
- S. Shaikh, M. S. Muneera, O. A. Thusleem, M. Tahir, and A. V. Kondaguli, “A simple RP-HPLC method for the simultaneous quantitation of chlorocresol, mometasone furoate, and fusidic acid in creams,” Journal of Chromatographic Science, vol. 47, no. 2, pp. 178–183, 2009.
- I. Staub and A. M. Bergold, “Determination of ketoconazole in shampoo by high performance liquid chromatography,” Acta Farmaceutica Bonaerense, vol. 23, no. 3, pp. 387–390, 2004.
- R. U. Peter and U. Richarz-Barthauer, “Successful treatment and prophylaxis of scalp seborrhoeic dermatitis and dandruff with 2% ketoconazole shampoo: results of a multicentre, double-blind, placebo-controlled trial,” British Journal of Dermatology, vol. 132, no. 3, pp. 441–445, 1995.
- C. Piérard-Franchimont, G. E. Piérard, J. E. Arrese, and P. de Doncker, “Effect of ketoconazole 1% and 2% shampoos on severe dandruff and seborrhoeic dermatitis: clinical, squamometric and mycological assessments,” Dermatology, vol. 202, no. 2, pp. 171–176, 2001.
- R. Giordani, J. Trebaux, M. Masi, and P. Regli, “Enhanced antifungal activity of ketoconazole by Euphorbia characias latex against Candida albicans,” Journal of Ethnopharmacology, vol. 78, no. 1, pp. 1–5, 2001.
- J. Boonleang and C. Tanthana, “Simultaneous stability-indicating hplc method for the determination of cisapride, methylparaben and propylparaben in oral suspension,” Songklanakarin Journal of Science and Technology, vol. 32, no. 4, pp. 379–385, 2010.
- European Medicines Agency, “Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product,” Doc. Ref. EMEA/CHMP/QWP/396951/ 2006, London, UK, 2006.
- ICH Q6A, “Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances,” in International Conference on Harmonization, 1999.
- X. W. Teng, K. Foe, K. F. Brown, D. J. Cutler, and N. M. Davies, “High-performance liquid chromatographic analysis of mometasone furoate and its degradation products: application to in vitro degradation studies,” Journal of Pharmaceutical and Biomedical Analysis, vol. 26, no. 2, pp. 313–319, 2001.
- J. Zhu and C. Coscolluella, “Chromatographic assay of pharmaceutical compounds under column overloading,” Journal of Chromatography B, vol. 741, no. 1, pp. 55–65, 2000.
- J. C. H. Donovan and J. G. DeKoven, “Cross-reactions to desoximetasone and mometasone furoate in a patient with multiple topical corticosteroid allergies,” Dermatitis, vol. 17, no. 3, pp. 147–151, 2006.
- H. C. Korting, K. Maslen, G. Gross, and C. Willers, “Comparison of activity of different topical corticosteroid creams and ointments using a vasoconstriction assay: superiority of hydrocortisone butyrate over hydrocortisone,” Journal of the German Society of Dermatology, vol. 3, no. 5, pp. 348–353, 2005.
- K. A. Shaikh and A. T. Patil, “Stability-indicating HPLC method for the determination of mometasone furoate, oxymetazoline, phenyl ethanol and benzalkonium chloride in nasal spray solution,” Journal of Trace Analysis in Food and Drugs, vol. 1, pp. 14–21, 2013.
- USP 29 NF 24, United States Pharmacopoeia, U.S. Pharmacopeial Convention, Rockville, MD, USA, 2006.
- The United States Pharmacopoeia, 32th NF 27, Ketoconazole, United States Pharmacopeial Convention, Rockwille, MD, USA, pp.2737–2738, 2009.
- European Pharmacopoeia, Ketoconazole 01/2008:0921 corrected 6.0, European Pharmacopoeia Commission, 6th edition, 2008.
- E. R. M. Kedor-Hackmann, M. M. F. Nery, and M. I. R. M. Santoro, “Determination of ketoconazole in pharmaceutical preparations by ultraviolet spectrophotometry and HPLC,” Analytical Letters, vol. 27, no. 2, pp. 363–376, 1994.
- A. Kumar, P. Srinivas, K. Spandana, N. Rama, and J. VidyaSagar, “Rapid and sensitive HPLC method for the determination of sirolimus with ketoconazole as internal standard and its further applications,” International Journal of Pharmaceutical Sciences Drug Research, vol. 4, no. 1, pp. 70–73, 2012.
- R. K. Jat, S. Sharma, R. C. Chhipa, R. Singh, and I. Alam, “Development and validation of RP-HPLC method for estimation of ketoconazole in bulk drug,” Pharmacophore, vol. 3, no. 2, pp. 123–129, 2012.
- V. K. Venishetty, N. Parikh, R. Sistla, F. J. Ahmed, and P. V. Diwan, “Application of validated RP-HPLC method for simultaneous determination of docetaxel and ketoconazole in solid lipid nanoparticles,” Journal of Chromatographic Science, vol. 49, no. 2, pp. 136–141, 2011.
- R. A. Mhaske and S. Sahasrabudhe, “Identification of major degradation products of Ketoconazole,” Scientia Pharmaceutica, vol. 79, no. 4, pp. 817–836, 2011.
- Y. V. Heyden, A. N. M. Nguyet, M. R. Detaevernier, D. L. Massart, and J. Plaizier-Vercammen, “Simultaneous determination of ketoconazole and formaldehyde in a shampoo: liquid chromatography method development and validation,” Journal of Chromatography A, vol. 958, no. 1-2, pp. 191–201, 2002.
- A. N. M. Nguyet, L. Tallieu, J. Plaizier-Vercammen, D. L. Massart, and Y. V. Heyden, “Validation of an HPLC method on short columns to assay ketoconazole and formaldehyde in shampoo,” Journal of Pharmaceutical and Biomedical Analysis, vol. 32, no. 1, pp. 1–19, 2003.
- E. M. Abdel-Moety, F. I. Khattab, K. M. Kelani, and A. M. AbouAl-Alamein, “Chromatographic determination of clotrimazole, ketoconazole and fluconazole in pharmaceutical formulations,” Farmaco, vol. 57, no. 11, pp. 931–938, 2002.
- M. V. Vertzoni, C. Reppas, and H. A. Archontaki, “Optimization and validation of a high-performance liquid chromatographic method with UV detection for the determination of ketoconazole in canine plasma,” Journal of Chromatography B, vol. 839, no. 1-2, pp. 62–67, 2006.
- K. H. Yuen and K. K. Peh, “Simple high-performance liquid chromatographic method for determination of ketoconazole in human plasma,” Journal of Chromatography B, vol. 715, no. 2, pp. 436–440, 1998.
- S. Bajad, R. K. Johri, K. Singh, J. Singh, and K. L. Bedi, “Simple high-performance liquid chromatography method for the simultaneous determination of ketoconazole and piperine in rat plasma and hepatocyte culture,” Journal of Chromatography A, vol. 949, no. 1-2, pp. 43–47, 2002.
- D. A. Hamdy and D. R. Brocks, “A stereospecific high-performance liquid chromatographic assay for the determination of ketoconazole enantiomers in rat plasma,” Biomedical Chromatography, vol. 22, no. 5, pp. 542–547, 2008.
- P. de Bruijn, D. F. S. Kehrer, J. Verweij, and A. Sparreboom, “Liquid chromatographic determination of ketoconazole, a potent inhibitor of CYP3A4-mediated metabolism,” Journal of Chromatography B, vol. 753, no. 2, pp. 395–400, 2001.
- I. Staub, L. Flores, G. Gosmann et al., “Photostability studies of ketoconazole: isolation and structural elucidation of the main photodegradation products,” Latin American Journal of Pharmacy, vol. 29, no. 7, pp. 1100–1106, 2010.
- B. Gjorgjeska, “Determination of ketoconazole in tablets by using three different methods,” European Medical, Health and Pharmaceutical Journal, vol. 4, p. 8, 2012.
- P. Arranz, A. Arranz, J. M. Moreda, A. Cid, and J. F. Arranz, “Stripping voltammetric and polarographic techniques for the determination of anti-fungal ketoconazole on the mercury electrode,” Journal of Pharmaceutical and Biomedical Analysis, vol. 33, no. 4, pp. 589–596, 2003.
- Q. Huang, G.-J. Wang, J.-G. Sun, X.-L. Hu, Y.-H. Lu, and Q. Zhang, “Simultaneous determination of docetaxel and ketoconazole in rat plasma by liquid chromatography/electrospray ionization tandem mass spectrometry,” Rapid Communications in Mass Spectrometry, vol. 21, no. 6, pp. 1009–1018, 2007.
- G. Chen, B. N. Pramanik, Y.-H. Liu, and U. A. Mirza, “Applications of LC/MS in structure identifications of small molecules and proteins in drug discovery,” Journal of Mass Spectrometry, vol. 42, no. 3, pp. 279–287, 2007.
- S. Sahasranaman, Y. Tang, D. Biniasz, and G. Hochhaus, “A sensitive liquid chromatography-tandem mass spectrometry method for the quantification of mometasone furoate in human plasma,” Journal of Chromatography B, vol. 819, no. 1, pp. 175–179, 2005.
- Y.-L. Chen, L. Felder, X. Jiang, and W. Naidong, “Determination of ketoconazole in human plasma by high-performance liquid chromatography-tandem mass spectrometry,” Journal of Chromatography B, vol. 774, no. 1, pp. 67–78, 2002.
- I. Velikinac, O. Čudina, I. Janković, D. Agbaba, and S. Vladimirov, “Comparison of capillary zone electrophoresis and high performance liquid chromatography methods for quantitative determination of ketoconazole in drug formulations,” Farmaco, vol. 59, no. 5, pp. 419–424, 2004.
- K.-L. Kuo and Y.-Z. Hsieh, “Determination of preservatives in food products by cyclodextrin-modified capillary electrophoresis with multiwavelength detection,” Journal of Chromatography A, vol. 768, no. 2, pp. 334–341, 1997.
- J. L. Bernal, M. J. del Nozal, L. Toribio, M. I. Montequi, and E. M. Nieto, “Separation of ketoconazole enantiomers by chiral subcritical-fluid chromatography,” Journal of Biochemical and Biophysical Methods, vol. 43, no. 1–3, pp. 241–250, 2000.
- K. Farhadi and R. Maleki, “New spectrophotometric method for the determination of ketoconazole based on the oxidation reactions,” Analytical Sciences, vol. 17, pp. 867–870, 2001.
- E. R. M. Kedor-Hackmann, M. I. R. M. Santoro, A. K. Singh, and A. C. Peraro, “First-derivative ultraviolet spectrophotometric and high performance liquid chromatographic determination of ketoconazole in pharmaceutical emulsions,” Brazilian Journal of Pharmaceutical Sciences, vol. 42, no. 1, pp. 91–98, 2006.
- M. M. Ayad, M. M. EL-Henawee, H. E. Abdellatef, and H. M. EL Sayed, “Spectrophotometric determination of levonorgestrel, norethisterone acetate, mometasone furoate and fluticasone propionate using 4-amino-antipyrine,” Cairo Bull, vol. 43, no. 3, 2005.
- A. Kulkarni, N. Rabindra, and N. Ranjane, “Simultaneous estimation of Nadifloxacin and Mometasone Furoate in topical cream by HPTLC method,” Der Pharma Chemica, vol. 2, no. 3, pp. 25–30, 2010.
- “Stability testing of new drug substances and products, Q1A (R2),” in International Conference on Harmonization (ICH '03), IFPMA, Geneva, Switzerland, 2003.
- ICH, Validation of Analytical Procedure, Text and Methodology Q2 (R1), IFPMA, Geneva, Switzerland, 2005.