SELECTIVE LIQUID CHROMATOGRAPHIC QUANTIFICATION OF BETAMETHASONE VALERATE AND CLIOQUINOL IN PRESENCE OF POTENTIAL INTERFERENTS

Authors

  • Hayam Mahmoud Lotfy Analytical chemistry department, faculty of pharmacy - cairouniversity, kasr el-aini post, et-11562cairo, egypt
  • Ezzat Mohamad Abdel-moety Analytical chemistry department, faculty of pharmacy - cairouniversity, kasr el-aini post, et-11562cairo, egypt
  • Eman Galal Nouman makin research center(mrc), 9 zone,nasr city,cairo,egypt

Keywords:

Betamethasone, Clioquinol, Degradation, HPLC, Stability, potential interferents

Abstract

Objective: To develop and justify a validated simple and selective RP-HPLC method for simultaneous determination of betamethasone valerate (BETA), clioquinol (CLIO) together with their potential interferents including their proposed degradation products, the preservatives methyl paraben (MPB) and propyl paraben (PPB) as well as gentamycin and tolnaftate.

Methods: Degradation products of betamethasone and clioquinol were prepared then the technique was built using an efficient chromatographic separation on a Zorbax C18 column (25 cm×4.6 mm, 5.0 μm) using water- methanol-acetonitrile- glacial acetic acid (394: 50: 550: 6, v/v/v/v) as mobile phase and the eluent was monitored at 275 nm.

Results: The developed method was linear over the concentration ranges of 12-240 mg mL-1, 30-3000 mg mL-1, 7-140 mg mL-1 and 3.5-70 mg mL-1 forBETA, CLIO, MPB and PPB, respectively, with high degree of accuracy and precision.

Conclusion: The method was successfully applied for the analysis of BETA and CLIO in their pharmaceutical preparations and their combined formulation with gentamycin and tolnaftate. Recoveries were quantitative, and the results obtained agreed with those obtained by official methods.

Downloads

Download data is not yet available.

References

The British Pharmacopoeia, Her Majesty's Stationary Office, London. Contact Dermatitis. 2010.

Johansen JD, Frosh PJ and lepoittevin JP, Contact Dermatitis, Springer,Verlag, Berlin, Heidelberg 2008;pages 417 and 131.

Smith EW, Haigh JM, Kanfer I. A stability-indicating HPLC assay with on-line clean-upfor betamethasone 17-valerate in topical dosage forms. J Pharm Res 1989;6(5), 431-8.

Hansen J, Bundgaard H. Studies on the stability of corticosteroids VI. kinetics of the rearrangement of betamethasone-17-valerate to the 21-valerate ester in aqueous solution. Int J Pharmaceutics 1981;8(2) 121-9.

Yip YW, Po LW. The stability of betamethasone-17-valerate in semi-solid bases. J Pharm Pharmacol 1979;31(6):400-2.

Ryatt KS, Feather JW, Mehta A, Dawson JB, Cotterill JA, Swallow R. The stability and blanching efficacy of betamethasone-17-valerate in emulsifying ointment. Br J Dermatol 1982;107(1):71-6.

Ryatt KS, Cotterill JA, Mehta A.The effect of serial dilution of betamethasone-17-valerate on blanching potential and chemical stability. J Clin Hosp Pharm 1983;8(2):143-5.

Li M, Lin M, Rustum A. Application of LC-MS(n) in conjunction with mechanism-based stress studies in the elucidation of drug impurity structure:rapid identification of a process impurity in beta methasone 17-valerate drug substance. J Pharm Biomed Anal 2008;48(5), 1451-56.

Manufacturing K, Volume F. Handbook of Pharmaceutical Niazi, Taylor & Francis. Contact Dermatitis. 2004;4.

Placzek M, Krosta I, Gaube S, Eberlein-konig B, Przybilla B. Evaluation of phototoxic properties of antimicrobials used in topical preparations by a photohaemolysis test. J Acta Derm Venereol 2005;5 (85):13-6.

Przybilla B, Georgii A, Bergner T, Ring J. Demonstrationof quinolone phototoxicity. J In vitro Dermatologica 1990;181:98-103.

Da-zhang Z, Dong-mei S, Shi-long W, Xiao-yu S, Ya-ming N, Si-de Y. Degradation of quinoline in aqueous solution by the light of 185 nm/254 nm, 2nd. J Int Conference on Bioinformatics and Biomedical Engineering iCBBE 2008;p. 3051-55.

Indrayanto G, Widjaja S, Sutiono S. Simultaneous densitometric determinationof betamethasone valerate and miconazole nitrate in creamand its validation. J Liq Chromatogr Relat Technol 1999;22(1):143-52.

Indrayanto G, Aditama L, Tanudjaja W & Widjaja S. Simultaneous densitometric determination of betamethasone valerate and clotrimazole incream and its validation. J Planar Chromator Mod TLC 1998;11(3):201-04.

Indrayanto G, Wahyuninglish I, Salim RJ. Simultaneous densitometric determination of betamethasone valerate and clioquinol incream and its validation. J Planar Chromator Mod TLC 1997;10(3):204-07.

Min L, Mingxiang L, Rustum A. Application of LC–MS inconjunction with mechanism-based stress studies in the elucidation of drug impurity structure:rapid identification of a process impurity in betamethasone 17-valerate drug substance. J Pharm Bio Anal 2008;48(5):1451-56.

Smith EW & Haigh JM. Stability indicating high-performance liquid-chromatographic assay for betamethasone valerate in purified isopropyl myristate receptor phase. J Pharm Res 1989;6(5):431-5.

Susumu O, Nori K, Katsuyoshi K. HPLC Determination of betamethasone-17-valerate in commercial ointment and admixtures. J Nippon Hospital Pharmacists 1984;10(5):370-4.

Huri MFD, Shiow-Fern NG and Zulfakar MH. Fish oil-based oleogels:Physicochemicals characterization and In vitro release of betamethasone dipropionate. Int J Pharm Pharm Sci 2013;5(3).

Bondiolotti GP, Pollera C, Pirola R, Bareggi SR. Determinationof clioquinol in plasma and tissues of hamsters by high-performance liquid chromatography and electrochemical detection. J Chromatogr B:Anal Technol-Biomed-Life-Sci 2006;837(1-2),:87-91.

Rizk M, Belal F, Ibrahim F, Ahmed S, Sheribah ZA. Liquidof pharmaceutically important halogenated 8-hydroxyquinolines after precolumn derivatization with Pd(II). J Pharm Biomed Anal 2002;27(5):813-20.

Ray S. Estimation of memitazole and clioquinol in single and combined dosage formsby HPLC. J East Pharm 1990;33(389):139-41.

Wojtowicz EJ. Reversed-phase liquid chromatographic determination of clioquinol in cream and ointment preparations. J Assoc Off Anal Chem 1989;72(4):562-3.

Bandyopadhyay A, Podder G, Sen AK, Roy S, Moitra SK, Das TK. High-performance reversed-phase liquid-chromatographic and spectrophotometric determination of clioquinol. J Indian Drugs 1989;26(9):506-9.

Moore RA, Carter AJ. Assay of iodochlorhydroxyquinoline (clioquinol) in cream and ointment formulations by high-performance liquid chromatography. J Pharm Biomed Anal 1988;6(4):427-31.

Ezzedeen FW, Stohs SJ, Stublar M. High-performance liquid chromatographic analysis of clioquinol and hydrocortisone in ointmentsand creams. J Pharm Sci 1983;72(9):1036-39.

27. Matsuki Y, Ito T, Fukuhara K, Othaki M, Nambara T. Determination of clioquinol in biological fluids and nervous tissues of dog by gas chromatography-mass spectrometry. J Arch Toxicol 1987;59(5):374-8.

28. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Harmonized Triplicate Guideline on Validation of Analytical Procedures:Methodology, Recommended for Adoption at Step 4 of the ICH Process on November 1996 by the ICH Steering Committee, IFPMA, Switzerland.

29. Elsayed SM, Nazif NM, Hassan RA, Hassanein HD, Elkholy YM, Gomaa NS and Shahat AA. Chemical and biological conistituents from the leaf extracts of the wild artichoke. Int J Pharm Pharm Sci 2012;4(5)

Published

01-07-2014

How to Cite

Lotfy, H. M., E. M. Abdel-moety, and E. G. Nouman. “SELECTIVE LIQUID CHROMATOGRAPHIC QUANTIFICATION OF BETAMETHASONE VALERATE AND CLIOQUINOL IN PRESENCE OF POTENTIAL INTERFERENTS”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 7, July 2014, pp. 79-85, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/1223.

Issue

Section

Original Article(s)