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 (r2, 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.

Keywords

• Apomorphine
• HPLC
• Pharmaceuticals
• Quality control

References

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