DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DOLASETRON MESYLATE
Keywords:Dolasetron mesylate, HPTLC, Stability indicating method
Objective: To develop and validate stability indicating HPTLC method for determination of Dolasetron mesylate.
Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using Methanol: Choloroform: Ethyl acetate (7:2:1 v/v/v) as mobile phase followed by densitometric scanning at 280 nm.
Results: The chromatographic condition gave a compact spot for Dolasetron mesylate at Rf value of 0.65Â±0.03. Stress testing was performed in accordance with international conference on harmonization (ICH) Q1A R2 guidelines. Method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 100-800 ng/band for Dolasetron mesylate. The limit of detection and quantification was found to2.24 ng/band and 6.79 ng/band, respectively.
Conclusion: A new sensitive, simple, and stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for determination of Dolastron mesylate. The proposed method can be used for routine determination of Dolasetron mesylate stability.
Miller RC, Galvan M, Gittos MW, Giersbergen P, Moser PC, Fozard JR. Pharmacological properties of dolasetron, a potent and selective antagonist at 5-HT3 receptors. Drug Dev Res 1993;28:84-93.
Lerman K, Sikich N. Pharmacokinetics of the active metabolite (MDL 74,156) of dolasetron mesylate after oral or intravenous administration to anesthetized children. Int J Clin Pharmacol Ther 1996;60(5):485-92.
United States Pharmacopoeia XXX, National Formulary 25. Asian edition. Rockville, MD USP Convention CD-ROM Version; 1986. p. 8.
Mcelvain J, Vandiver VJ, Eichmeier LS. Validation of a reversed-phase HPLC method for directly quantifying the enantiomers of MDL 74, 156, the primary metabolite of dolasetron mesylate in human plasma. J Pharm Biomed Anal 1997;15(4):513-21.
Johnson CE, Wagner DS, Bussard WE. Stability of Dolasetron in two oral liquid vehicles. Am J Health-Syst Pharm 2003;60:2242-4.
Huebert ND, Schwartz JJ. Simultaneous measurement of Dolasetron and its major metabolite, MDL 74,156, in human plasma/urine. J Chromatogr B: Biomed Appl 1996;685(2):291-7.
Sanwald P, Huebert ND. Simultaneous measurement of the major metabolites of dolasetron mesylate in human urine using solid-phase extraction and high-performance liquid chromatography. J Chromatogr B: Biomed Sci Appl 1994;661(1):101-7.
Hu Y, Chen S, Chen J, Liu G, Chen B, Yao S. Optimization of sample pretreatment methods for simultaneous determination of dolasetron and Hydrodolasetron in human plasma by HPLC-ESI-MS. JCS 2012;50:785-91.
Gillespie TA, Eckstein JA, Nardella P, Coutant JE. Determination of dolasetron and its reduced metabolite in human plasma by GCâ€”MS and LC. J Pharm Biomed Anal 1993;11(10):955â€“62.
ICH Harmonised Tripartite Guideline, Validation of analytical procedures: text and methodology Q1A(R2). Available from: URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q1A_R2/Step4/Q1A_R2_Guideline.pdf
ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q1B. Available from: URL: http://www.ich.org/file admin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1B/Step4/Q1B_Guideline.pdf
ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1). Available from: URL: http://www.ich.org/file admin/Public_Web_Site/ ICH_Products/ Guidelines/Quality/Q2_R1/Step4/Q2_R1_Guideline.pdf