Development of a Liquid Chromatographic Method for Apomorphine Hydrochloride Quantitation in the Active Pharmaceutical Ingredients and in the Dosage Forms
Development of a Liquid Chromatographic Method for Apomorphine Hydrochloride Quantitation in the Active Pharmaceutical Ingredients and in the Dosage Forms
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
___
- Referans1
Tysnes OB, Storstein A. 2017 Epidemiology of Parkinson’s disease. J Neural Transm. 124(8). 901–905.
- Referans2
Poewe W, Seppi K, Tanner CM, et al. 2017. Parkinson disease. Nat Rev Dis Primers. 3. 17013-17018
- Referans3
Kempster PA, Frankel JP, Stern GM, Lees AJ. 1990. Comparison of motor response to apomorphine and levodopa in Parkinson’s disease. J Neurol Neurosurg Psychiatry. 53(11).1004–1007.
- Referans4
Poewe WH, Lees AJ, Stern GM. 1986. Low-dose L-dopa therapy in Parkinson’s disease: a 6-year follow-up study. Neurology. 36(11).1528–1530.
Referans5
Sweet RD, McDowell FH. 1975. Five years’ treatment of Parkinson’s disease with levodopa. Therapeutic results and survival of 100 patients. Ann Intern Med. 83(4). 456–463.
Referans6
Ernst AM, Smelik PG. 1966. Site of action of dopamine and apomorphine on compulsive gnawing behavior in rats. Experientia. 22(12). 837–8.
- Referans7
Auffret M, Drapier S, Vérin M. 2018. Pharmacological insights into the use of apomorphine in parkinson’s disease: clinical relevance. Clin Drug Investig. 38(4). 287–312.
- Referans8
Millan MJ, Maiofiss L, Cussac D, Audinot V, Boutin J-A, Newman- Tancredi A. 2002. Differential actions of antiparkinson agents at multiple classes of monoaminergic receptor. I. A multivariate analysis of the binding profiles of 14 drugs at 21 native and cloned human receptor subtypes. J Pharmacol Exp Ther. 303(2). 791–804.
- Referans9
Jenner P, Katzenschlager R. 2016. Apomorphine pharmacological properties and clinical trials in Parkinson’s disease. Park Relat Disord. 33. 13–21.
- Referans10
Le Witt PA, Ondo WG, Van Lunen B, Bottini PB. 2009. Open-label study assessment of safety and adverse effects of subcutaneous apomorphine injections in treating ‘off’ episodes in advanced Parkinson disease. Clin Neuropharmacol. 32(2). 89–93.
- Referans11
Arppe AE. 1845. Ueber eine merkwürdige Veränderung des Morphins durch Schwefelsäure. Ann der Chemie und Pharm. 55(1). 96–101.
- Referans12
Matthiessen A, Wright CRA. 1868. Researches into the Chemical constitution of the opium bases. Part I. on the action of hydrochloric acid on morphia. Proc R Soc Lond. (1868) 17. 455–60
- Referans13
Taba P, Lees A, Stern G. 2013. Erich Harnack (1852-1915) and a short history of apomorphine. Eur Neurol. 69(6). 321–4.
- Refereans14
Pierce FM. 1870. Notes on Apomorphia. British Medical Jornal. 1(478). 204.
- Referans15
Hare F. 1912. On alcoholism its clinical aspects and treatment. London: J&A Churchill.
- Referans16
Gee S. 1869. On the action of a new organic base, apomorphia. Clin Soc Trans. 2. 166–9.
- Referans17
Taba, P., Lees, A., & Stern, G. 2013. Erich Harnack (1852–1915) and a short history of Apomorphine.
- Referans18
Raymond MJ. 1963. The treatment of addiction by aversive conditioning with apomorphine. Behav Res Ther. 1(2–4). 287–91.
- Referans19
Hughes AJ, Lees AJ, Stern GM. 1991. The motor response to sequential apomorphine in parkinsonian fluctuations. J Neurol Neurosurg Psychiatry. 358–60.
- Referans20
Stibe CMH, Kempster PA, Lees AJ, Stern GM. 1988. Subcutaneous apomorphine in Parkinsonian on-off oscillations. Lancet. 331(8582). 403–6.
- Referans21
Lemere F. 1987. Aversion treatment of alcoholism: some reminiscences. Addiction. 82(3). 257–8.
- Referans22
Mulhall JP. 2002. Sublingual apomorphine for the treatment of erectile dysfunction. Expert Opinion Investig Drugs. 11(2). 295–302.
- Referans23
De Weill E. 1884. l’apomorphine dans certains troubles nerveux. Lyon Med. 47. 411–18.
- Referans24
Yang B, Yu Y, Cai L, Deng C, Duan G. 2006. Determination of apomorphine in canine plasma by liquid chromatography-electrospray ionization mass spectrometry and its application to a pharmacokinetic study. J. Sep. Sci. 29. 2173–2178.
- Referans25
Tan, L. Chin, S.F. Miner, V.W. Dong, L. Gupta, S. & Fields, S.M. 2016. Determination of apomorphine freebase in sublingual tablets by proton nuclear magnetic resonance spectroscopy. Journal of pharmaceutical and biomedical analysis. 129. 378-382
- Referans26
Ang ZY, Boddy M, Liu Y, Sunderland B. 2016. Stability of apomorphine in solutions containing selected antioxidant agents. Drug Des Devel Ther. 10. 3253-65.
- Referans27
Apomorphine Hydrochloride Monographs. The United States Pharmacopeia (USP 32) Volume No. 32(5). 1438-39
- Referans28
Apomorphine Hydrochloride Tablets Monographs. The United States Pharmacopeia (USP 32). Volume No. 32(5). 1573-74
- Referans29
Apomorphine hydrochloride Monographs. European Pharmacopoeia (EP 6.0) 1206-1207
- Referans30.
ICH. 2005. Q2 (R1), harmonized tripartite guideline, validation of analytical procedures: text and methodology, In Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
- Referans31
Center for Drug Evaluation and Research (CDER). 1994. Reviewer Guidance: Validation of Chromatographic Methods. CMC, 3.