Development of a Liquid Chromatographic Method for Apomorphine Hydrochloride Quantitation in the Active Pharmaceutical Ingredients and in the Dosage Forms

Abstract

Apomorphine is currently used as a dopamine agonist to treat advanced Parkinson Disease. In the present study, we developed a sensitive, simple, reliable, and robust HPLC method for quality control of apomorphine hydrochloride in bulk drug and pharmaceutical formulations. C18 column was used for separation. Isocratic elution was performed using mobile phase A: 50 mM potassium dihydrogen phosphate solution (pH:3 with ortho-phosphoric acid), B: acetonitrile in the ratio of 85:15 (A: B), and the mobile-phase flow rate was kept at 1 mL˖min -1 . Analyses were carried out at 272 nm using a UV detector. A perfect linear relationship between peak-area versus drug concentration in the range of 10-100 μg˖mL -1 was observed (r 2 , 0.9999). It has been found that the developed method is sensitive (Detection and quantification limits were determined as 1.3 μg˖mL -1 and 3.8 μg˖mL -1 , respectively), precise (RSD<0.9%, for repeatability and <1.2% for intermediate precision, inside appropriate precision ranges), accurate (recovery in various dosage forms, 99.68-100.56%, in a reasonable range, 80-120%), specific and robust (RSD% <0.80, for system suitability parameters). The proposed method for the determination of apomorphine hydrochloride in pharmaceutical formulations has been successfully applied.