Stability indicating RP-HPLC-PDA method for the estimation of quetiapine fumarate in bulk and pharmaceutical dosage forms
ABSTRACT:
The present study describes development and subsequent validation of a stability indicating reverse-phase HPLC method for the estimation of Quetiapine Fumarate (QF) in bulk and pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a Inertsil ODS (250 x 4.6 mm, 5µ) column, at ambient temperature, optimum mobile phase consisted of 0.02%v/v formic acid and methanol (90:10), effluent flow monitored at 1mL/min and UV detection at 220nm. The retention time of QF was 13.4min. The bulk active pharmaceutical ingredient was subjected to thermal, photolytic, hydrolytic (acidic and basic) and oxidative stress conditions and stressed samples were analyzed by the proposed method. Considerable degradation was found to occur only in oxidative stress conditions. The method was validated as per ICH guidelines, a good linearity was observed in the concentration range of 10- 50µg/mL with a correlation coefficient (R) of >0.999 and method showed good repeatability and reproducibility with percent relative standard deviation less than 2%. The percent assay and recovery values were found to be in the range of 98.56-99.06% and 99.60-100.85% respectively. The proposed RP-HPLC-PDA method is specific, accurate, precise and high sensitive enough for the estimation of QF in bulk and pharmaceutical dosage forms.
The present study describes development and subsequent validation of a stability indicating reverse-phase HPLC method for the estimation of Quetiapine Fumarate (QF) in bulk and pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a Inertsil ODS (250 x 4.6 mm, 5µ) column, at ambient temperature, optimum mobile phase consisted of 0.02%v/v formic acid and methanol (90:10), effluent flow monitored at 1mL/min and UV detection at 220nm. The retention time of QF was 13.4min. The bulk active pharmaceutical ingredient was subjected to thermal, photolytic, hydrolytic (acidic and basic) and oxidative stress conditions and stressed samples were analyzed by the proposed method. Considerable degradation was found to occur only in oxidative stress conditions. The method was validated as per ICH guidelines, a good linearity was observed in the concentration range of 10- 50µg/mL with a correlation coefficient (R) of >0.999 and method showed good repeatability and reproducibility with percent relative standard deviation less than 2%. The percent assay and recovery values were found to be in the range of 98.56-99.06% and 99.60-100.85% respectively. The proposed RP-HPLC-PDA method is specific, accurate, precise and high sensitive enough for the estimation of QF in bulk and pharmaceutical dosage forms.
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