VALIDATED STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ASENAPINE MALEATE
Keywords:Antipsychotic drug, Stress degradation, High performance liquid chromatography, Quantification
Objective: A stability indicating high performance liquid chromatography method using the photodiode array detector is developed and validated for the analysis of asenapine in bulk and in its tablet formulation.
Methods: The method utilized a BDS Y Persil C18 (250 x 4.6 mm, 5 µm) column with 0.1% orthophosphoric acid and methanol (65:35 v/v) as mobile phase. The analysis was performed at 30 oC column temperature with a flow rate of 1 ml/min and detection at 227 nm. The method was validated for specificity, sensitivity, precision, linearity, accuracy and robustness. Asenapine was subjected to stress degradation studies under acidic, basic, oxidative, thermal and photolytic conditions.
Results: Under optimized experimental conditions, asenapine was eluted from the column at a retention time of 6.781 min. The method was linear in the range of 100-300 µg/ml. The linear regression data showed good relationship (correlation coefficient (R2) = 0.9999). The relative standard deviation and mean recovery values were within limits. The analytical performance of the method was not affected when small variations in the experimental parameters were made. Degradation products resulting from stress degradation studies did not interfere with the detection of asenapine.
Conclusion: The proposed stability indicting high performance liquid chromatography method is sensitive, precise, accurate, robust and specific. This method can be used for quantification of asenapine in bulk drug and in tablet dosage form in the presence of its stress degradation products.
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