Stability-indicating HPTLC method for quantitation of quetiapine fumarate in the pharmaceutical dosage form

• Autorzy: Dhaneshwar S. R. , Patre N. G. , Mahadik M. V.
• Języki publikacji: EN

Abstrakty

EN

A sensitive, selective, precise, and stability-indicating HPTLC method for quantitative analysis of quetiapine fumarate both as the bulk drug and in formulations has been established and validated. The stationary phase was silica gel and the mobile phase toluene-methanol 8:2 (v/v). This system gave compact bands for quetiapine fumarate ( R F 0.37 š 0.02). Densitometric analysis of quetiapine fumarate was performed in absorbance mode at 254 nm. There was no chromatographic interference from tablet excipients. Quetiapine fumarate was subjected to acid and alkaline hydrolysis, oxidation, and photodegradation. The drug is susceptible to all these treatments. The degradation products were well resolved from the pure drug with substantially different R F values. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Because the method can effectively separate the drug from its degradation products, it can be used as a stability indicating method.

Słowa kluczowe

EN

quetiapine fumarate; HPTLC; validation; stability-indicating method

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2009
• Tom: Vol. 21, no. 1
• Strony: 83--93
• Opis fizyczny: Bibliogr. 9 poz., rys., tab.

Twórcy

autor

Dhaneshwar S. R.

autor

Patre N. G.

autor

Mahadik M. V.

• Bharati Vidyapeeth University, Poona College of Pharmacy Department of Pharmaceutical Chemistry Pune 411038 India,

Bibliografia

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