DOI: https://doi.org/10.18524/2304-0947.2017.1(61).94713
ВИЗНАЧЕННЯ ЗАЛИШКОВИХ КІЛЬКОСТЕЙ РИВАСТИГМІНУ ГІДРОТАРТРАТУ НА ПОВЕРХНЯХ ФАРМОБЛАДНАННЯ МЕТОДАМИ ВЕРХ ТА ЛЮМІНЕСЦЕНЦІЇ
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PIC/S document PI006-2. Recommendations on Validation Master Plan, Installation und Operational Qualfication. Non Sterile Process Validation, Cleaning Validation, July 2004.
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Egorova A.V., Fedosenko A.A., Mal’cev G.V., Antonovich V.P. Validacija metodik kontrolja kachestva ochistki farmacevticheskogo oborudovanija Analitika i kontrol’, 2015, vol. 19, no 4, pp. 387–395. http://dx.doi.org/10.15826/analitika.2015.19.4.002 (in Russian)
Shabir G.A. Equipment Cleaning Valiation: Developing an HPLC Method to Determine Contamination Residues on Equipment Surfaces Am. Pharm. Rev., 2008, vol. 11, pp. 16–22.
Schmidt A.H., Stanic M. UPLC-MS/MS in support of cleaning validation studies in an cephalosporin antibiotics production facility G.I.T. Laboratory J. Europe, 2012, vol. 5-6, pp. 28.
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Fakutsu N., Konse T., Kawasaki T., Saito K., Nakazawa H. Determination of cefmetazole residue at pharmaceutical manufacturing facilities by chemiluminescence flow injection analysis J. Pharm. Biomed. Anal., 2006, vol. 41, pp. 599–602. http://dx.doi.org/10.1016/j.jpba.2005.11.038
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Sharmila S., Bhargavi K., Abdul Rahaman S.K. Method development and validation of rivastigmine by visible spectrophotometry J. Pharm. Mol. Biol., 2014, vol. 2, no 2, pp. 5-5.
Amini H., Ahmadiani Ab. High-Performance liquid chromatographic determination of rivastigmine in human plasma for application in pharmacokinetic studies Iran J. Pharm. Res., 2010, vol. 9, no 2, pp. 115-121.
Arumugam K., Chamallamudi M., Mallayasamy S., Mullangi R., Ganesan S., Jamadar L., Ranjithkumar A., Udupa N. High performance liquid chromatographic fluorescence detection method for the quantification of rivastigmine in rat plasma and brain: application to preclinical pharmacokinetic studies in rats J. Young Pharm., 2011, vol. 3, no 4, pp. 315-321. http://dx.doi.org/10.4103/0975-1483.90244
Choudhury A., Pai K.V., Dey S., Mandade R.J. RP-HPLC method for the estimation of rivastigmine in bulk and in dosage forms // J. Pharm. Research., 2011, vol. 4, no 4, pp. 1007-1009.
Reddy T.V., Gowri K. A novel RP-HPLC and visible spectrophotometric methods for the quantification of rivastigmine in bulk and pharmaceutical formulations Int. J. Pharm. Chem. Sci., 2013, vol. 2, no 2, pp. 851-857.
European Pharmacopoeia. 7th edition. EP 8.6. Rivastigmine hydrogen tartrate., 2013, (monograph 2630).
Derzhavna Farmakopeja Ukraїni Derzhavne pіdpriєmstvo “Naukovo-ekspertnij farmakopejnij centr”. 1-e vid. Harkіv, RІREG, Dopovnennja 2, 2008, pp. 97-100. (in Ukranian)
Пристатейна бібліографія ГОСТ
1. PIC/S document PI006-2. Recommendations on Validation Master Plan, Installation und Operational Qualfication. Non Sterile Process Validation, Cleaning Validation; July 2004.
2. Гармонов С.Ю., Нурисламова Г.Р., Фатхуллин P.P., Горюнова С.М. Проблемы перекрестного загрязнения в химико-фармацевтическом производстве: стандартизация и унификация требований // Вестник Казанского технол. универ.. – 2006. – Т. 6. – С. 294-305.
3. Nassani M. Cleaning validation in the pharmaceutical industry // J. Validation Technol. – 2005. – Р. 11 -14.
4. Fourman G.L., Mullen M.V. Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations // Pharm. Technol. – 1993. – Vol. 17. – P. 54-60.
5. Егорова А.В., Федосенко А.А., Мальцев Г.В., Антонович В.П. Валидация методик контроля качества очистки фармацевтического оборудования // Аналитика и контроль – 2015. – Т. 19, № 4. – С. 387–395. http://dx.doi.org/10.15826/analitika.2015.19.4.002
6. Shabir G.A. Equipment Cleaning Valiation: Developing an HPLC Method to Determine Contamination Residues on Equipment Surfaces // Am. Pharm. Rev. – 2008. – Vol. 11. – P. 16–22.
7. Schmidt A. H., Stanic M. UPLC-MS/MS in support of cleaning validation studies in an cephalosporin antibiotics production facility // G.I.T. Laboratory J. Europe. – 2012. – Vol. 5-6. – P. 28.
8. Георгиевский В.П., Георгиевский Г.В., Зинченко А.А., Куликов А.Ю., Назарова Е.С., Колиснык А.В. Хроматографические методы в аналитическом обеспечении создания и контроля качества лекарственных средств в Украине. Под ред. В.П. Георгиевского. Харьков: изд. «НТМТ». 2016. – 288 с.
9. Peles D.N., Ely K.J., Crowder T.M., Ponstingl M. Rapid at-line pharmaceutical cleaning verification using a novel light induced fluorescence (LIF) sensor // J. Pharm. Biomed. Anal. – 2013 – Vol. 72. – P. 1-7. http:// dx.doi.org/10.1016/j.jpba.2012.09.018
10. Fakutsu N., Konse T., Kawasaki T., Saito K. , Nakazawa H. Determination of cefmetazole residue at pharmaceutical manufacturing facilities by chemiluminescence flow injection analysis // J. Pharm. Biomed. Anal. – 2006 – Vol. 41. – P. 599–602. http://dx.doi.org/10.1016/j.jpba.2005.11.038
11. Кондратьева М.Л., Наприенко Е.Н., Шкуратова О.В. Разработка аналитических методик для валидации очистки оборудования, используемого в производстве лекарственных средств // Сибирский медицинский журнал – 2011. – T. 26, № 2-2. – C. 84–97.
12. Glover C. Validation of the total organic carbon (TOC) swab sampling and test method. // J. Pharm. Sci. Technol. 2006. – Vol. 60, N 5. – Р. 284–290.
13. Sharmila Sk., Srilakshmi. M, Renukadevi. G, Rahaman S.A., Shanthakumari K. Development and validation of UV-spectrophotometric method for the estimation of rivastigmine tartrate in bulk and pharmaceutical dosage form // IAJPR. – 2013. – Vol. 3, N 10. – P. 8394-8399.
14. Sharmila S., Bhargavi K., Abdul Rahaman S.K. Method development and validation of rivastigmine by visible spectrophotometry // J. Pharm. Mol. Biol. – 2014. – Vol. 2, N 2. – P. 5-5.
15. Amini H., Ahmadiani Ab. High-Performance liquid chromatographic determination of rivastigmine in human plasma for application in pharmacokinetic studies // Iran J. Pharm. Res. – 2010. – Vol. 9, N 2. – P. 115-121.
16. Arumugam K., Chamallamudi M., Mallayasamy S., Mullangi R., Ganesan S., Jamadar L., Ranjithkumar A., Udupa N. High performance liquid chromatographic fluorescence detection method for the quantification of rivastigmine in rat plasma and brain: application to preclinical pharmacokinetic studies in rats // J. Young Pharm. – 2011. – Vol. 3, N 4. – P. 315-321. http://dx.doi.org/10.4103/0975-1483.90244
17. Choudhury A., Pai K.V., Dey S., Mandade R.J. RP-HPLC method for the estimation of rivastigmine in bulk and in dosage forms // J. Pharm. Res. – 2011. – Vol. 4, N 4. – P. 1007-1009.
18. Reddy T.V., Gowri K. A novel RP-HPLC and visible spectrophotometric methods for the quantification of rivastigmine in bulk and pharmaceutical formulations // Int. J. Pharm. Chem. Sci. – 2013. – Vol. 2, N 2. – P. 851-857.
19. European Pharmacopoeia. 7th edition. EP 8.6. Rivastigmine hydrogen tartrate. – 2013. – (monograph 2630).
20. Державна Фармакопея України/Державне підприємство “Науково-експертний фармакопейний центр”. – 1-е вид. – Харків: РІРЕГ. – Доповнення 2 –2008. – C. 97-100.

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