Vol. 8, Issue 12 (2019)

Author(s):
K Pansuriya, P Parejiya, D Suthar, P Shelat, A Vekariya and H Patel

Abstract:
Asenapine Maleate is a atypical antipsychotic drug. It was approved by USFDA in august 2009. It is an antagonist of 5-HT dopamine and α-adrenergic receptors and high affinity for dopamine D₂ and serotonin 5-HT_2A receptor. It is indicated for treatment of various psychotic conditions like schizophrenia and bipolar disorder in adults. So it leads to the requirement of accurate and precise quantification in its bulk and buccal (effervescent) dosage form. The analytical method was developed and validate as per ICH guideline. The proposed RS-HPLC method fulfill the need at 100.8% accuracy with precision of 0.25% relative standard deviation. Waters alliance HPLC system with column Inertsil ODS 3V (150mm × 4.6mm, 5µm) having UV-detector at 270 nm wavelength was used. Mobile phase having mixture of 550 mL Acetonitrile and 450 mL of Milli-Q water and 1mL Ortho Phosphoric Acid (OPA) was used. The flow rate was set to 1.5 mL/min that give the retention time at 4.9 min for Asenapine Maleate. The method is found linear (r²=0.999 and R=1) for concentration range of 50 ppm to 75 ppm with zero percent interference at specificity. Robustness of the proposed method provides the back support for analysis of sample in unfavorable laboratory condition and instrumental variation. This method can be easily transferable to quality control laboratory and even at institution platform too.