Araştırma Makalesi
Yıl 2021,
Cilt: 4 Sayı: 2, 44 - 50, 26.12.2021
Öz
Kaynakça
- 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.
Development of a Liquid Chromatographic Method for Apomorphine Hydrochloride Quantitation in the Active Pharmaceutical Ingredients and in the Dosage Forms
Öz
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.
Anahtar Kelimeler
Kaynakça
- 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.
Toplam 29 adet kaynakça vardır.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Kimya Mühendisliği |
| Bölüm | Araştırma Makaleleri |
| Yazarlar | |
| Yayımlanma Tarihi | 26 Aralık 2021 |
| Kabul Tarihi | 10 Eylül 2021 |
| Yayımlandığı Sayı | Yıl 2021 Cilt: 4 Sayı: 2 |
Kaynak Göster
