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2 Acta Chromatographica

2 2009

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

Dhaneshwar S. R., Patre N. G., Mahadik M. V.

Acta Chromatographica

2009

Vol. 21, no. 1

83-93

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.

Application of a stability-indicating HPTLC method for quantitative analysis of amtolmetin guacil in a pharmaceutical dosage form

Bhusari V. K., Mahadik M. V., Dhaneshwar S. R.

Acta Chromatographica

2009

Vol. 21, no. 2

299--317

A sensitive, selective, precise, and stability-indicating HPTLC method has been established for analysis of amtolmetin guacil both as the bulk drug and in a formulation. Aluminum foil-backed silica gel 60F 254 plates were used with toluene-ethyl acetate 4:6 ( υ/υ ) as mobile phase, and densitometric analysis was performed in absorbance mode at 320 nm. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Amtolmetin guacil was subjected to acidic and alkaline hydrolysis, oxidation, dry heat treatment, and photo-degradation. The method was used to study the kinetics of degradation of amtolmetin guacil by acid and alkali.