Development, Validation and Forced Degradation Study of Beclomethason Dipropionate in Bulk and Pharmaceutical Dosage Form by HPTLC Method

Objective:-The Present work describes the development and validation of a new simple, accurate, precise and stability-indicating HPTLC method for the determination of Beclomethason Dipropionate in the capsule dosage form. Methods:-The chromatographic separation was achieved by using Ethyl acetate: T...

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Veröffentlicht in:NeuroQuantology 2022-01, Vol.20 (13), p.1392
Hauptverfasser: BavkarManasiM, Andhale, Ganesh S, Shelar, Madhuri, Kadam, Jyoti N, Singh, Sonia, Nagare, Sapana
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Sprache:eng
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Zusammenfassung:Objective:-The Present work describes the development and validation of a new simple, accurate, precise and stability-indicating HPTLC method for the determination of Beclomethason Dipropionate in the capsule dosage form. Methods:-The chromatographic separation was achieved by using Ethyl acetate: Toluene: Formic acid (4:6:0.2 v/v/v) as mobile phase and UV detection at 252nm with Rf value 0.64. This developed method was validated based on linearity, accuracy, precision, the limit of detection, the limit of quantitation and robustness as per ICH guidelines. Result:-The described method was linear over a concentration range of 200-1000 ng/band with correlation coefficient (r2)> 0.9995. The recovery was found to be 98.14%. The limit of detection (LOD) and the limit of quantification (LOQ) for Beclomethason was found to be 28.30 ng/band and 85.76 ng/band respectively. The drug was shows a stress conditions of acid hydrolysis, alkali hydrolysis, photolysis, thermal degradation.Conclusion:-The proposed stabilityindicating method can be used for the determination of Beclomethason Dipropionate in bulk samples and in the pharmaceutical dosage form
ISSN:1303-5150
DOI:10.14704/nq.2022.20.13.NQ88173