15 references

August 27, 2017 | Autor: Windy Novita | Categoría: Chemistry
Share Embed


Descripción

176

REFERENCES

1. Snyder, L.R., Kirkland, J.J., 1979, “Introduction to Modern Liquid Chromatography” Wiley, New York. 2. Lloyd R, Snyder., Joseph J, Kirkland., Joseph L, Glajch, 1997, “Practical HPLC method development,” 2nd Edition, John Wiley & Sons, Canada, pp. 9, 13, 685. 3. Bennett, P.K., 2006, Proceedings of the “Applied Pharmaceutical Analysis Meeting,” Boston Society of Advanced Therapeutics, Boston, MA. 4. Bennett, P.K., Meng, M., ˇC´apka, V., 2006, Presented at the 17th “International Mass Spectrometry Conference,” Prague, Czech Republic, 5. Ikonomou, M.G., Kebarle, P., 1994, “A Heated Electrospray Source for Mass Spectrometry of Anlaytes From Aqueous Solutions,” Journal of American Society for Mass Spectrometry, 5, pp. 791-799. 6. Forngren, B.H., Samskog, J., Gustavsson, S.A., Tyrefors, N., Markides, K.E., Langstrom, B., 1999, “Reverse Phase Ion-Pair Chromatography Coupled to Electrospray Ionization Mass Spectrometry, by On-Line Removal of the Counter Ions,” Journal of Chromatography A., 854, pp. 155-162. 7. Xu, R.N., Fan, L., Rieser, M.J., El-Shourbagy, T.A., 2007, “Recent Advances in High- Throughput Quantitative Bioanalysis by LC-MS/MS,” Journal of Pharmaceutical and Biomedical Analysis, 44, pp. 342-355. 8. Charles R, Craig, Robert E, Stitzel, 2004, “Modern Pharmacology with Clinical Applications,” 6th Edition, Lippincott Williams & Wilkins, pp. 763. 9. Goodman, Gillman, 1996, “The Pharmacological Basis of Therapeutics,” 10th Edition, McGraw Hill Companies Inc., pp. 1679-1715. 10. Satoskar, R.S., Bhandarkar, S.D., Nirmala, N., 2001, “Pharmacology and Pharmacotherapeutics,” 17th Edition, Popular Prakashan Ltd., India. pp. 893. 11. Burger, A. 1986, “Drugs and People: Medications, Their History and Origins, and the Way They Act,” University Press of Virginia, USA, pp.4.

177

12. Lesney, M.S., 2000, “Patents and Positions: Entering the pharmaceutical Century, The Pharmaceutical century: Ten decades of drug discovery” supplements to American Chemical Society, pp. 18. 13. Pizzi, R., 2000, “Salving with Science: The roaring twenties and the great depression, The Pharmaceutical century: Ten decades of drug discovery” supplements to American Chemical Society, pp. 34. 14. Frey, R., Lesney, M.S., 2000, “Anodynes and Estrogens: The pharmaceutical Decade, The Pharmaceutical century: Ten decades of drug discovery” supplements to American Chemical Society pp. 92. 15. Henderson, R., 1994, “Managing Innovation in the Information Age,” Harvard Business Review, pp. 100. 16. Tsinopoulos, C., McCarthy, I., 2001, “The Evolution of Strategies for Drug Discovery: From Accidental Discovery to Rational Drug Design, Proceedings of R & D management conference”, Dublin, pp. 467. 17. James Swarbrick, James C. Boylan, 1998, “Encyclopedia of Pharmaceutical Technology,” Marcel Dekker Inc, NY, Vol. I, pp. 217, 224. 18. Bressolle, F., Bromet-pitit, M., Audran, M., 1996, “Validation of Liquid Chromatography and Gas Chromatographic Methods Application to Pharmacokinetics,” J. Chromatogr. B., 686, pp. 3-10. 19. International Organization for Standardization, 1994, Accuracy of Measurement Methods and Results. ISO/DIS 5725-1 to 5725-3. 20. Karnes, H.T., Shiu, G., Shah, V.P., 1991, “Validation of Bioanalytical Methods,” Pharmacy Research, 8, pp. 421-426. 21. Lindner, W., Wainer, I.W., 1998, “Requirements for Initial Assay Validation,” Journal of Chromatography B., 707, pp. 1-2. 22. Shah, V.P., Midha, K.K., Dighe, S., McGilveray, I.J., Skelly, J.P., Yacobi, A., Layloff, T., Viswanathan, C.T., Cook, C.E., McDowall, R.D., Pittman, K.A., Spector, S., 1992, “Analytical method validation: Bioavailability, Bioequivalence and Pharmacokinetic studies,” Conference report. Pharm. Res., 9, pp. 588-592. 23. Shah, V.P., Midha, K.K., Findlay, J.W., Hill, H.M., Hulse, J.D., McGilveray, I.J., McKay, G., Miller, K.J., Patnaik, R.N., Powell, M.L., Tonelli, A., Viswanathan, C.T., Yacobi, A., 2000, “Bioanalytical Method

178

Validation- a Revisit With a Decade of Progress,” Pharma Research, 17, pp. 1551-1557. 24. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Bioanalytical Method Validation. http://www.fda.gov/cder/guidance/index.htm. 2001. 25. Miro, M., Hansen, E.H., 2008, “On-line Processing Methods in Flow Analysis, in: M. Trojanowicz (Ed.),” Advances in Flow Methods of Analysis, Wiley-VCH, Weinhem, Germany, Chap. 11, pp. 320. 26. Hartmann, C., Smeyers -Verbeke, J., Massart, D.L., McDowall, R.D., 1998, “Validation of Bioanalytical Chromatographic Methods,” Journal of Pharmaceutical and Biomedical Analysis, 17, pp. 193-218. 27. Anonymous, May 2001. Guide for Industry, Bioanalytical Method Validation, U.S Department of Health and Human Services Food and Drug Administration (FDA). 28. Douglas, A, Skoog., Holler, F, James., Nieman, A, Timothy, 2001, “Principles of Instrumental Analysis,” 5th Edition, Harcourt Asia PTE Ltd., pp. 673. 29. Gary D., Christan, 2003, “Analytical Chemistry,” 6th Edition, Wiley-VCH, USA. 30. Kasture, A.V., Mahadik, K.R., Wadodkar, S.G., More, H.N., 2002, “Pharmaceutical Analysis,” Vol. I & II, Nirali Prakashan, Pune, India. 31. IUPAC; Compendium of chemical terminology, 2nd edn. International Union of Pure Applied Chemistry, Research Triangle Park, NC (1997). 32. LaCourse, W.R., 2002, “Column liquid chromatography: Equipment and Instrumentation,” Analytical Chemistry, 74, pp. 2813-2832. 33. Albert, K., 2002, “On-line LC–NMR and Related Techniques,” Eds. Wiley, Chichester, UK 34. Skoog, D.A., Holler, F.J., Nieman, T.A., 1998, “Principles of Instrumental Analysis”, 5th Edition, Saunders, Philadelphia. 35. Giddings, J.C., 1991, “Unified Separation science”, Wiley, New York.

179

36. Lloyd R, Snyder., Joseph J, Kirkland., Joseph L, Glajch, 1997, “Practical HPLC method development,” 2nd Edition, John Wiley & Sons, Canada, pp. 9, 13, 685. 37. Joel K, Swadesh., 2000, “HPLC- Practical and Industrial Applications, Analytical Chemistry Series,” 2nd Edition, CRC Press, FL, USA. 38. Stavros Kromidas, 2006, “HPLC Made to Measure, A Practical Handbook for Optimization,” Wiley-VCH, Verbg, GmbH & Co KGaA, Weinheim, Germany. 39. Madhusudan N. Saraf, Pramod G. Birajdar, Punnamchand Loya, Siddharth A. Mukherjee, 2007, “Rapid and Sensitive HPTLC Method for Determination of Epalrestat in Human Plasma,” Journal of Planar Chromatograpy- A Modern TLC, 20, pp. 203-207. 40. Yang Wan-Hua, Yu Cheng-Yi, 2000, “Pharmacokinetics of Epalrestat After a Single and Multiple Oral Dose in Healthy Volunteers,” The Chinese Journal of Clinical Pharmacology, 16, pp. 205-208. 41. Christelle Gedeon, Bhushan Kapur, Katarina Aleksa, Gideon Koren, 2008, “A Simple and Rapid HPLC Method for the Detection of Glyburide in Plasma,” Clinical Biochemistry, 41, pp. 167-173. 42. Ioannis Niopas, Athanasios C. Daftsios, 2002, “A Validated HighPerformance Liquid Chromatographic Method for the Determination of Glibenclamide in Human Plasma and its Application to Pharmacokinetic Studies,” Journal of Pharmaceutical and Biomedical Analysis, 28, pp. 653657. 43. Gulshan Bansal, Manjeet Singh, Kaur Chand Jindal, 2007, “Forced Degradation Study on Gliclazide and Application of Validated StabilityIndicating HPLC-UV Method in Stability Testing of Gliclazide Tablets,” Chromatographia., 66, pp. 751-755. 44. Guixia Ling, Jin Sun, Jingling Tang, Xiaodi Xu, Yinghua Sun, Zhonggui He, 2006, “LC-ESI Mass Spectrometric Method for Determination of Gliclazide in Human Plasma,” Analytical Letters, 39, pp. 1381-1391. 45. Yannis Dotsikas, Constantinos Kousoulos, Georgia Tsatsou, Yannis L., Loukas, 2005, “Development of a Rapid Method for the Determination of Glimepiride in Human Plasma using Liquid-Liquid Extraction Based on 96well Format Micro-Tubes and Liquid Chromatography/Tandem Mass

180

Spectrometry,” Rapid Communications in Mass Spectrometry, 19, pp. 2055-2061. 46. Sacide Altinoz, Dilara Tekeli, 2001, “Analysis of Glimepiride by Using Derivative UV Spectrophotometric Method,” Journal of Pharmaceutical and Biomedical Analysis, 24, pp. 507-515. 47. Ghoneima, E.M., El-Attar, M.A., Hammama, E., Khashaba, P.Y., 2007, “Stripping Voltammetric Quantification of the Anti-diabetic Drug Glipizide in Bulk Form and Pharmaceutical Formulation,” Journal of Pharmaceutical and Biomedical Analysis, 43, pp. 1465-1469. 48. Dhawan, S., Singla, A.K., 2003, “High Performance Liquid Chromatographic Analysis of Glipizide: Application to Invitro and Invivo Studies,” Journal of Chromatographic Science, 41, pp. 295-300. 49. Sakalgaonkar, A.A., Mirgane, S.R., Arbad, B.R., 2008, “Validated High Performance Liquid Chromatographic Stability Indicating Method for Analysis of Metformin HCl,” International Journal of Applied and Environmental Sciences, 3, pp. 65-73. 50. Collin, F., Khoury, H., Bonnefont-Rousselot, D., Therond, P., Legrand, A., Jore, D., Gard`es-Albert, M., 2004, “LC-ESI Mass Spectrometric Identification of the Oxidation End-Products of Metformin in Aqueous Solutions,” Journal of Mass Spectrometry, 39, pp. 890-902. 51. Ashour, S., Kabbani, R., 2003, “Direct Spectrophotometric Determination of Metformin hydrochloride in Pure Form and in Drug Formulations,” Analytical Letters, 36, pp. 361-370. 52. Zarghi, A., Foroutan, S.M., Shafaati, A., Khoddam, A., 2003, “Rapid Determination of Metformin in Human Plasma Using Ion-Pair HPLC,” Journal of Pharmaceutical and Biomedical Analysis, 31, pp.197-200. 53. Ching-Ling Cheng , Chen-Hsi Chou, 2001, “Determination of Metformin in Human plasma by High-Performance Liquid Chromatography With Spectrophotometric Detection,” Journal of Chromatography B., 762, pp. 5158. 54. Florentin Tache, Victor Davida, Alexandru Farca, Andrei Medvedovici, 2001, “HPLC-DAD Determination of Metformin in Human Plasma Using Derivatization With p-nitrobenzoyl chloride in a Biphasic System,” Microchemical Journal, 68, pp. 13-19.

181

55. Saad S.M., Hassan, Wagiha H., Mahmoud, Mohamed A.F., Elmosallamy, Abdel Hammeed M. Othman, 1999, “Determination of Metformin in Pharmaceutical Preparations Using Potentiometry, Spectrofluorimetry and UV-Visible Spectrophotometry,” Analytica Chimica Acta., 378, pp. 299311. 56. Kah Hay Yuen, Kok Khiang Peh, 1998, “Simple High-Performance Liquid Chromatographic Method for the Determination of Metformin in Human Plasma,” Journal of Chromatography B., 710, pp. 248-246. 57. Ole Vesterqvist , Fizal Nabbie, Brian Swanson, 1998, “Determination of Metformin in Plasma by High-Performance Liquid Chromatography After Ultrafiltration,” Journal of Chromatography B., 716, pp. 299-304. 58. Kanthi Kiran V.S., Varanasi, Sridhar, V., Suresh, P., Shraddha, R., Sivakumar, S.P.N., Kanaga Sabapathi, S., Satheeshmanikandan, T.R.S., Swaroop Kumar, V.V.S., 2008, “Development and Validation of a Liquid Chromatography/Tandem Mass Spectrometry Assay for the Simultaneous Determination of Nateglinide, Cilostazol and Its Active Metabolite 3,4dehydro-cilostazol in Wistar Rat Plasma and Its Application to Pharmacokinetic Study,” Journal of Chromatography B., 865, pp. 91-98. 59. Danai Malli, Evagelos Gikas, Andreas Vavagiannis, Michael Kazanis, Konstantinos Daniilides, Dimitra Gennimata, Irene Panderi, 2007, “Determination of Nateglinide in Human Plasma by High-Performance Liquid Chromatography With Pre-Column Derivatization Using a Coumarin-Type Fluorescent Reagent,” Analytica Chimica Acta., 599, pp. 143-150. 60. Jolly M., Sankalia, Mayur G., Sankalia, Vijay B., Sutariya, Rajashree C., Mashru, 2007, “Nateglinide Quantification in Rabbit Plasma by HPLC: Optimization and Application to Pharmacokinetic Study,” Journal of Pharmaceutical and Biomedical Analysis, 44, pp. 196-204. 61. Junfa Yin, Gengliang Yang, Yi Chen, 2005, “Rapid and Efficient Chiral Separation of Nateglinide and Its L-Enantiomer on Monolithic Molecularly Imprinted Polymers,” Journal of Chromatography A., 1090, pp. 68-75. 62. Hongyuan Yan, Gengliang Yang, Fengxia Qiao, Yi Chen, 2004, “Determination of Nateglinide in Animal Plasma by Micellar Electrokinetic Chromatography and On-Line Sweeping Technique,” Journal of Pharmaceutical and Biomedical Analysis, 36, pp. 169-174.

182

63. Steffen Bauer, Elke Stormer, Julia Kirchheiner, Claudia Michael, Jurgen Brockmoller, Ivar Roots, 2003, “Rapid and Simple Method for the Analysis of Nateglinide in Human Plasma Using HPLC Analysis With UV Detection,” Journal of Pharmaceutical and Biomedical Analysis, 31, pp. 551-555. 64. Wanjari, D.B., Gaikwad, N.J., 2005, “Stability Indicating RP-HPLC Method for Determination of Pioglitazone From Tablets,” Indian Journal of Pharmaceutical Sciences, 67, pp. 256-258. 65. Zhongping John Lin, Weihua Ji, Daksha Desai-Krieger, Linyee Shum, 2003, “Simultaneous Determination of Pioglitazone and Its Two Active Metabolites in Human Plasma by LC/MS/MS,” Journal of Pharmaceutical and Biomedical Analysis, 33, pp. 101-108. 66. Radhakrishna, T., Sreenivas Rao, D., Om Reddy, G., 2002, “Determination of Pioglitazone hydrochloride in Bulk and Pharmaceutical Formulations by HPLC and MEKC Methods,” Journal of Pharmaceutical and Biomedical Analysis, 29, pp. 593-607. 67. Kenji Yamashita, Hiromi Murakami, Teruaki Okuda, Michio Motohashi, 1996, “High-Performance Liquid Chromatographic Determination of Pioglitazone and Its Metabolites in Human Serum and Urine,” Journal of Chromatography B., 677, pp. 141-146. 68. Zhong, W.Z., Williams, M.G., 1996, “Simultaneous Quantitation of Pioglitazone and Its Metabolites in Human Serum by Liquid Chromatography and Solid Phase Extraction,” Journal of Pharmaceutical and Biomedical Analysis, 14, pp. 465-473. 69. Abu Bakar Ruzilawati, Mohd Suhaimi Abd. Wahab, Ahmad Imran, Zabidah Ismail, Siew Hua Gan, 2007, “Method Development and Validation of Repaglinide in Human Plasma by HPLC and Its Application in Pharmacokinetic Studies,” Journal of Pharmaceutical and Biomedical Analysis, 43, pp. 1831-1835. 70. Vipul P., Rane, Devanand B., Shinde, 2007, “A Validated Chiral LC Method for the Enantiomeric Separation of Repaglinide on Amylose Based Stationary Phase,” Chromatographia, 66, pp. 583-587. 71. He, J., Hu, Y.F., Duan, L.F., Tan, Z.R., Wang, L.S., Wang, D., Zhang, W., Li, Z., Liu, J., Tu, J.H., Yao, Y.M., Hong-Hao Zhou, 2007, “Sensitive and Selective Liquid Chromatography–Mass Spectrometry Method for the

183

Quantification of Rosiglitazone in Human Plasma,” Pharmaceutical and Biomedical Analysis, 43, pp. 580-585.

Journal

of

72. Chi-Chi Chou, Maw-Rong Lee, Fu-Chou Cheng, Dar-Yu Yang, 2005, “Solid-Phase Extraction Coupled With Liquid Chromatography–Tandem Mass Spectrometry for Determination of Trace Rosiglitazone in Urine,” Journal of Chromatography A., 1097, pp. 74-83. 73. Patr´ıcia Gomes, Juliana Sippel, Andr´e Jablonski, Martin Steppe, 2004, “Determination of Rosiglitazone in Coated Tablets by MEKC and HPLC Methods,” Journal of Pharmaceutical and Biomedical Analysis, 36, 909913. 74. Ramakrishna, N., Vishwottam, K., Koteshwara, M., Prashanth, K., Raghupathi, A., Rajeshkumar, B., 2008, “Sensitive Liquid Chromatography Tandem Mass Spectrometry Method for the Quantification of Sitagliptin, a DPP-4 Inhibitor, in Human Plasma Using Liquid–Liquid Extraction,” Biomedical Chromatography, 22, pp. 214-222. 75. Wei Zeng, Donald G., Musson, Alison L., Fisher, Li Chen, Michael S., Schwartz, Eric J., Woolf, Amy Qiu Wang, 2008, “Determination of Sitagliptin in Human Urine and Hemodialysate Using Turbulent Flow Online Extraction and Tandem Mass Spectrometry,” Journal of Pharmaceutical and Biomedical Analysis, 46, pp. 534-542. 76. Jong Soo Woo, Jae Kuk Ryu, 2006, “Quantitative Determination of Voglibose in Pharmaceutical Tablets Using High-Performance Liquid Chromatography–Fluorescence Detection With Post-Column Derivatization and Mass Spectrometric Detection,” Journal of Pharmaceutical and Biomedical Analysis, 42, pp. 328-333. 77. Deepti Jain, Surendra Jain, Deepak Jain, Maulik Amin, 2008, “Simultaneous Estimation of Metformin hydrochloride, Pioglitazone hydrochloride, and Glimepiride by RP-HPLC in Tablet Formulation,” Journal of Chromatographic Sciences, 46, pp. 501-504. 78. Karthik, A., Subramanian, G., Mallikarjuna Rao, C., Krishnamurthy Bhat, Ranjithkumar, A., Musmade, P., Surulivelrajan, M., Karthikeyan, K., Udupa, N., 2008, “Simultaneous Determination of Pioglitazone and Glimepiride in Bulk Drug and Pharmaceutical Dosage Form by RP-HPLC Method,” Pakistan Journal of Pharmaceutical Sciences, 21, pp. 421-425.

184

79. Bytul M. Rahman, Mukhlesur Rahman, M., Maruf Ahmed, Robiul Islam, M., Mir Imam Ibne Wahed, Ranjan Kr Barman, Abdur Rashid Khan, M., Belal Hossain, M., Shah Amran, Md., 2007, “Simultaneous HPLC Determination of Metformin hydrochloride and Rosiglitazone maleate in Pharmaceutical-dosage Form,” Research Journal of Medicine and Medical Sciences, 2, pp. 115-121. 80. Ceren Yardımcı, Nuran Ozaltın, 2007, “Simultaneous Determination of Rosiglitazone and Metformin in Pharmaceutical Preparations by LC,” Chromatographia, 66, pp. 589-593. 81. Hiren N., Mistri, Arvind G., Jangid, Pranav S. Shrivastav, 2007, “Liquid Chromatography Tandem Mass Spectrometry Method for Simultaneous Determination of Antidiabetic Drugs Metformin and Glyburide in Human Plasma,” Journal of Pharmaceutical and Biomedical Analysis, 45, pp. 97106. 82. Cun-Gang Ding, Zhen Zhou, Qing-Hua Ge, Xiao-Jin Zhi, Li-Li Ma, 2007, “Simultaneous Determination of Metformin and Glipizide in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry,” Biomedical Chromatography, 21, pp. 132-138. 83. Jing Yao, Ya-Qin Shi, Zhuo-Rong Li, Shao-Hong Jin, 2007, “Development of a RP-HPLC Method For Screening Potentially Counterfeit Anti-Diabetic Drugs,” Journal of Chromatography B., 853, pp. 254-259. 84. Lu Zhang, Yuan Tian, Zunjian Zhang and Yun Chen, 2007, “Simultaneous Determination of Metformin and Rosiglitazone in Human Plasma by LCMS/MS: Application to a Pharmacokinetic Study,” Journal of Chromatography B., 854, pp. 91-98. 85. Ghassempour, A., Ahmadi, M., Ebrahimi, S.N., Aboul-Enein, H.Y., 2006, “Simultaneous Determination of Metformin and Glyburide in Tablets by HPTLC,” Chromatographia, 64, pp. 104-106. 86. Venkatesh, P., Harisudhan, T., Hira Choudhury, Ramesh Mullangi, Nuggehally R., Srinivas, 2006, “Simultaneous Estimation of Six AntiDiabetic Drugs- Glibenclamide, Gliclazide, Glipizide, Pioglitazone, Repaglinide and Rosiglitazone: Development of a Novel HPLC Method for Use in the Analysis of Pharmaceutical Formulations and Its Application to Human Plasma Assay,” Biomedical Chromatography, 20, pp. 1043-1048.

185

87. Aburuz, S., Millership, J., McElnay, J., 2005, “The Development and Validation of Liquid Chromatography Method for the Simultaneous Determination of Metformin and Glipizide, Gliclazide, Glibenclamide or Glimepiride in Plasma,” Journal of Chromatography B., Analytical Technology and Biomedical Life Sciences, 817, pp. 277-286. 88. Anna Gumieniczek, Hanna Hopkala, Anna Berecka, 2005, “RP-TLC of Three New Oral Antidiabetics and Densitometric Determination of Pioglitazone,” Journal of Liquid Chromatography and Related Technologies, 27, pp. 2057-2070. 89. Ceren Yardımcı, Nuran ¨Ozaltın, 2005, “Method Development and Validation for the Simultaneous Determination of Rosiglitazone and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis,” Analytica Chimica Acta., 549, pp. 88-95. 90. Guo-ping Zhong, Hui-chang Bi, Shufeng Zhou, Xiao Chen, Min Huang, 2005, “Simultaneous Determination of Metformin and Gliclazide in Human Plasma by LC-MS/MS: Application to a Bioequivalence Study of Two Formulations in Healthy Volunteers,” Journal of Mass Spectrometry, 40, pp. 1462-1471. 91. Bhaskar Laxmanrao Kolte, Bharat Baburao Raut, Adwait Anant Deo, Manoj Anil Bagoo, Devanand Baburao Shinde, 2005, “Simultaneous Determination of Metformin and Glimepride in Pharmaceutical Dosage Form by Reverse-Phase Liquid Chromatography,” Journal of Separation Science, 28, pp. 2076-2079. 92. Shankar Madhira, B., Modi Vaibhav, D., Shah Dimal, A., Bhatt Kashyap, K., Mehta Rajendra, S., Geetha Madhira, Patel Binita, J., 2005, “Estimation of Pioglitazone hydrochloride and Metformin hydrochloride in Tablets by Derivative Spectrophotometry and Liquid Chromatographic Methods,” Journal of AOAC International, 88, pp. 1167-1172. 93. Emmie N.M. Ho, Kenneth C.H. Yiu, Terence S.M. Wana, Brian D., Stewart, Keith L., Watkins, 2004, “Detection of Anti-Diabetics in Equine Plasma and Urine by Liquid Chromatography–Tandem Mass Spectrometry,” Journal of Chromatography B., 811, pp. 65-73. 94. Sane, R.T., Menon, S.N., Shafi Inamdar, Mandar Mote, Gunesh Gundi, 2004, “Simultaneous Determination of Pioglitazone and Glimepiride by

186

High Performance Liquid Chromatography,” Chromatographia, 59, pp. 451-453. 95. Kolte, B.L., Raut, B.B., Deo, A.A., Bagool, M.A., Shinde, D.B., 2003, “Simultaneous Determination of Metformin in Its Multi-Component Dosage Forms With Glipizide and Gliclazide Using Micellar Liquid Chromatography,” Journal of Liquid Chromatography and Related Technologies, 26, pp. 1117-1133. 96. Charles R, Craig, Robert E, Stitzel, 2004, “Modern Pharmacology with Clinical Applications,” 6th Edition, Lippincott Williams & Wilkins, pp. 763. 97. Goodman, Gilman, 1996, “The Pharmacological Basis of Therapeutics,” 10th Edition, McGraw Hill Companies Inc., pp. 1679-1715. 98. Satoskar, R.S., Bhandarkar, S.D., Nirmala, N., 2001, “Pharmacology and Pharmacotherapeutics,” 17th Edition, Popular Prakashan Ltd., India. pp. 893. 99. ICH guidelines, 1996, ICH harmonised tripartite guideline, International Conference on Harmonization of technical requirements for registration of Pharmaceuticals for human use, “Validation of Analytical Procedure: Methodology”. 100. Douglas A, Skoog, 1996, “Analytical Chemistry”, 7th Edition, Saunders College Publishers, Philadelphia, pp. 1-15. 101. Brain, W.W., Derek Cooper, 1991, “Analytical Chemistry by Open Learning” John Wiley & Sons, London, pp. 2-5. 102. Robert D, Brawn., 1987, “Introduction to Chemistry and Instrumental Analysis,” McGraw Hill Book Company, Singapore, pp. 1-13. 103. Jeffery, G.H., Bassett, J., 1991, “Vogel’s- Text Book of Quantitative Chemical Analysis,” 5th Edition, John Wiley & Sons Inc., NY, pp. 217235. 104. ICH, 2003 “ICH Q1A (R2): Stability Testing of New Drug Substances and Products”, pp. 5. 105. FDA, 1987, “Guideline for Submitting Documentation for the stability of Human Drugs and Biologics,” Centre for Drug and Biologics, Department of Health and Human Services.

187

106. ICH, 1996, “ICH Q2B Validation of Analytical Procedures, Terms and Definitions,” pp. 5. 107. ICH, 1994, “ICH Methodology,” pp. 5.

Q2A:

Validation

of

Analytical

Procedures,

108. Reynolds, D.W., Facchine, K.L., Mullaney, J.F., Alsante, K.M., Hatajik, T.D., Motto, M.G., 2002, “Available Guidance and Best Practices for Conducting Forced Degradation Studies,” Pharmaceutical Technology, 26, pp. 48-56. 109. Venn F. Richard, 2003, “Principles and Practice of Bioanalysis” 1st edition, Taylor & Francis Publication, pp. 225-274. 110. US-FDA, 2001, “US-FDA Guidance for Industry, Bioanalytical Method Validation” U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), BP. 111. ICH, 2005, “Validation of Analytical Procedures: Text and Methodology Q2 (R1)” ICH Harmonized Triplicate Guidelines, Current Step 4 Version.

Lihat lebih banyak...

Comentarios

Copyright © 2017 DATOSPDF Inc.