DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE THIN LAYER CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF POSACONAZOLE IN FORMULATION
DOI:
https://doi.org/10.22159/ajpcr.2023.v16i4.47048Keywords:
Posaconazole, High-performance thin layer chromatography, Silica gel 60 F254Abstract
Objective: The study aims to developed and validate novel high performance thin layer chromatographic method for estimation of posaconazole in tablet dosage form and validate as per the international conference on harmonization (ICH) guidelines.
Methods: The method was developed on silica gel 60 F254 HPTLC plates and the mobile phase was used as toluene: chloroform: ethanol in ratio (5:4:1 V/V/V). Densitometric analysis of Posaconazole was performed at the wavelength 265 nm.
Results: The RF of Posaconazole was found to be 0.331. The calibration curve was found to be linear in the concentration range of 100–500 ng/band. The correlation coefficient is 0.9991 for Posaconazole. The precision result was found to be satisfactory, which indicate that the method is precise. The recovery value lies in the range of 98–102% indicating the accuracy of the method.
Conclusion: A new, simpleaccurate, fast, economic, precise, and robust high performance thin layer chromatographic method was developed for the estimation of Posaconazole. The method is selective, specific it was applied in pharmaceutical analysis of Posaconazole tablet dosage form.
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References
Garcia CV, Costa GR, Mendez AS. Stability-indicating HPLC method for posaconazole bulk assay. Sci Pharm 2012;80:317-27.
Tang PH. Determination of posaconazole in plasma/serum by high-performance liquid chromatography with fluorescence detection. Separations 2017;4:16.
Khalil HA, El-Yazbi AF, Hamdy DA, Belal TS. Application of HPTLC, spectrofluorimetry and differential pulse voltammetry for determination of the antifungal drug posaconazole in suspension dosage form. Ann Pharm Fr 2019;77:382-93. doi: 10.1016/j.pharma.2019.04.004, PMID 31138437
Dewani MG, Borole TC, Gandhi SP, Madgulkar AR, Damle MC. Development and validation of HPTLC method for determination of voriconazole in human plasma. Der Pharm Chem 2011;3:201-9.
Sonia K, Shree BB, Lakshmi KS. HPTLC method development and validation: An overview. J Pharm Sci Res 2017;9:652-7.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology ICH. Vol. Q2(R1); 2005.
Sherma J. Review of HPTLC in drug analysis: 1996-2009. J AOAC Int 2010;93:754-64. doi: 10.1093/jaoac/93.3.754, PMID 20629372
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