Property | Value |
Name | Validated High Performance Thin Layer Chromatographic Method for Quantitation of Paliperidone in the Presence of Degradation Products Formed Under ICH Recommended Stress Conditions |
Description | Shubhangi M Pawar1, Sunil R Dhaneshwar2* 1Research and Development Centre in Pharmaceutical Sciences and Applied chemistry, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, Maharashtra, India 411038. 2 Professor & Chairperson, Department of Pharm.Chemistry, RAK Medical & Health Sciences University, College of Pharmaceutical Sciences, Ras Al Khaimah Post Box No 11172 U.A.E.
Abstract:- This paper describes a sensitive, selective, precise and stability-indicating High Performance Thin Layer chromatographic method for the determination of paliperidone as a bulk drug and in formulation. The method uses aluminium plates precoated with silica gel 60F-254 as the stationary phase and solvent system ethyl acetate: toluene: ammonia 6:1:0.5 (v/v/v). Paliperidone was subjected to acid and alkali hydrolysis, oxidation, and photo degradation. The peaks of the degradation products were well resolved from that of the pure drug and had significantly different Rf values. The linear regression analysis data for the calibration plots showed a good linear relationship over concentration range of 150-1500 ng.spot-1. The mean values of the correlation coefficient, slope, and intercept were 0.9993 ± 0.09, 5.6432 ± 0.126, and 1097.5 ± 1.14, respectively. Statistical analysis showed that the method is repeatable, selective and can separate the drug from its degradation products and can be used to monitor stability.
Keywords:- High performance thin layer chromatography, Paliperidone, Validation, Stability indicating, Degradation. |
Filename | Sunil R Dhaneshwar and Shubhangi M Pawar....pdf |
Filesize | 522.87 kB |
Filetype | pdf (Mime Type: application/pdf) |
Creator | admin |
Created On: | 03/18/2012 00:00 |
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Maintained by | Editor |
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Last updated on | 04/20/2012 12:11 |
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