Development and validation of a stability-indicating HPTLC assay method for idebenone

• Autorzy: Rathi A. A , Dhamecha D. L , Dehghan M. H. G , Saifee M , Wakte P. S , Shelke S. D. , Dongre S. H
• Języki publikacji: EN

Abstrakty

EN

A simple, selective, precise, and stability-indicating high-performance thin layer chromatographic (HPTLC) method has been established and validated for the analysis of idebenone in bulk drug and formulations. The compounds were analyzed on aluminum-backed silica gel 60 F254 plates with petroleum ether-methanol (4:1, υ/υ) as mobile phase. Densitometric analysis of idebenone was performed at 282 nm. Regression analysis data for the calibration plots were indicative of good linear relationship between response and concentration over the range of 200–600 ng per spot. The correlation coefficient (r2) was 0.989 ± 0.002. The values of slope and intercept of the calibration plots were 2.386 ± 0.0435 and 577.733 ± 19.545, respectively. The method was validated for precision, accuracy, robustness, and ruggedness. The limits of detection and quantification were 14.642 and 44.369 ng, respectively. Idebenone was subjected to acid, base, peroxide, and sunlight degradation. In stability tests, the drug was susceptible to acid and basic hydrolysis, oxidation, and photodegradation.

Słowa kluczowe

EN

HPTLC; idebenone; stability-indicating assay; validation; stress testing

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2011
• Tom: Vol. 23, no. 2
• Strony: 281--294
• Opis fizyczny: Bibliogr. 14 poz., rys., tab.

Twórcy

autor

Rathi A. A

• Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India

autor

Dhamecha D. L

• Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India

autor

Dehghan M. H. G

• Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India

autor

Saifee M

• Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India

autor

Wakte P. S

• University Department of Chemical Technology Dr. BAMU Aurangabad Maharashtra 431134 India

autor

Shelke S. D.

• ash Institute of Pharmacy South City, Bajaj Nagar P.O. Box 968 Waluj, Aurangabad Maharashtra 431134 India

autor

Dongre S. H

• ash Institute of Pharmacy South City, Bajaj Nagar P.O. Box 968 Waluj, Aurangabad Maharashtra 431134 India

Bibliografia

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