DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE DETERMINATION AND ESTIMATION OF ASENAPINE MALEATE IN BULK AND BUCCAL (EFFERVESCENT) DOSAGE FORM

Asenapine maleate is an atypical antipsychotic drug.  It was approved by USFDA in August 2009. It is an antagonist of 5-HT dopamine and α-adrenergic receptors and a high affinity for dopamine D₂ and serotonin 5-HT_2A receptors. It is indicated for the 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 validated as per ICH guidelines. The proposed RS-HPLC methods fulfill the need at 100.8% accuracy with a precision of 0.25% relative standard deviation. Waters Alliance HPLC system with column Inertsil ODS 3V (150 mm × 4.6 mm, 5 µm) having UV-detector at 270 nm wavelength was used. The mobile phase having a 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 gives the retention time at 4.9 min for Asenapine Maleate. The method is found linear (r² = 0.999 and R = 1) for a concentration range of 50 ppm to 75 ppm with zero percent interference at specificity. The robustness of the proposed method provides the back support for analysis of the sample in unfavorable laboratory conditions and instrumental variation. This method can be easily transferable to quality control laboratory and even at institution platform too.