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Volumn 42, Issue 12, 2009, Pages 1784-1804

Development and validation of stability-indicating hplc methods for quantitative determination of pravastatin, fluvastatin, atorvastatin, and rosuvastatin in pharmaceuticals

Author keywords

Method validation; Pharmaceuticals; Stability indicating RP HPLC; Statins

Indexed keywords


EID: 70449378435     PISSN: 00032719     EISSN: 1532236X     Source Type: Journal    
DOI: 10.1080/00032710903060669     Document Type: Article
Times cited : (51)

References (50)
  • 1
    • 0037307315 scopus 로고    scopus 로고
    • Sensitive assay for the determination of fluvastatin in plasma utilizing high-performance liquid chromatography with fluorescence detection
    • Al-Rawithi, S., R. F. Hussein, and A. Alzahrani. 2003. Sensitive assay for the determination of fluvastatin in plasma utilizing high-performance liquid chromatography with fluorescence detection. Ther. Drug Monit. 25: 88-89.
    • (2003) Ther. Drug Monit , vol.25 , pp. 88-89
    • Al-Rawithi, S.1    Hussein, R.F.2    Alzahrani, A.3
  • 2
    • 1342281612 scopus 로고    scopus 로고
    • Liquid chromatographic determination of atorvastatin in bulk drug, tablets, and human plasma
    • Altuntas, T. G., and N. Erk. 2004. Liquid chromatographic determination of atorvastatin in bulk drug, tablets, and human plasma. J. Liq. Chromatogr. Relat. Technol. 27: 83-93.
    • (2004) J. Liq. Chromatogr. Relat. Technol , vol.27 , pp. 83-93
    • Altuntas, T.G.1    Erk, N.2
  • 3
    • 26844439673 scopus 로고    scopus 로고
    • Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection
    • Bahrami, G., M. Bahareh, M. Shahla, and K. Amir. 2005. Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection. J. Chromatogr. B 826: 41-45.
    • (2005) J. Chromatogr. B , vol.826 , pp. 41-45
    • Bahrami, G.1    Bahareh, M.2    Shahla, M.3    Amir, K.4
  • 4
    • 14744303347 scopus 로고    scopus 로고
    • Quantification of pravastatin in human and urine after solid phase extraction using high performance liquid chromatography with ultraviolet detection
    • Bauer, S., J. Mwinyi, A. Stoeckle, T. Gerloff, and I. Roots. 2005. Quantification of pravastatin in human and urine after solid phase extraction using high performance liquid chromatography with ultraviolet detection. J. Chromatogr. B 818: 257-262.
    • (2005) J. Chromatogr. B , vol.818 , pp. 257-262
    • Bauer, S.1    Mwinyi, J.2    Stoeckle, A.3    Gerloff, T.4    Roots, I.5
  • 6
    • 84871109429 scopus 로고    scopus 로고
    • Validated HPLC-MS-MS method for simultaneous determination of atorvastatin and 2-hydroxyatorvastatin in human plasma-pharmacokinetic study
    • Borek-Dohalsky, V., J. Huclova, B. Barrett, B. Nemec, I. Ulc, and I. Jelinek. 2006. Validated HPLC-MS-MS method for simultaneous determination of atorvastatin and 2-hydroxyatorvastatin in human plasma-pharmacokinetic study. Anal. Bioanal. Chem. 386: 275-285.
    • (2006) Anal. Bioanal. Chem , vol.386 , pp. 275-285
    • Borek-Dohalsky, V.1    Huclova, J.2    Barrett, B.3    Nemec, B.4    Ulc, I.5    Jelinek, I.6
  • 8
    • 33846987580 scopus 로고    scopus 로고
    • Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products
    • Chaudhari, B. G., P. N. Manilal, and S. P. Bhagvatiprasad. 2007. Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products. Chem. Pharm. Bull. 55: 241-246.
    • (2007) Chem. Pharm. Bull , vol.55 , pp. 241-246
    • Chaudhari, B.G.1    Manilal, P.N.2    Bhagvatiprasad, S.P.3
  • 9
    • 33644756565 scopus 로고    scopus 로고
    • Chiral evaluation of fluvastatin in human plasma by high-performance liquid chromatography electrospray mass spectrometry
    • Di Pietro, G., D. B. Coelho, E. Barbosa, G. T. Magalhães, M. P. Marques, and V. L. Lanchote. 2006. Chiral evaluation of fluvastatin in human plasma by high-performance liquid chromatography electrospray mass spectrometry. J. Chromatogr. B 832: 256-261.
    • (2006) J. Chromatogr. B , vol.832 , pp. 256-261
    • di Pietro, G.1    Coelho, D.B.2    Barbosa, E.3    Magalhães, G.T.4    Marques, M.P.5    Lanchote, V.L.6
  • 10
    • 0141456434 scopus 로고    scopus 로고
    • Extractive spectrophotometric determination of atorvastatin in bulk and pharmaceutical formulations
    • Erk, N. 2003. Extractive spectrophotometric determination of atorvastatin in bulk and pharmaceutical formulations. Anal. Lett. 36: 2699-2711.
    • (2003) Anal. Lett , vol.36 , pp. 2699-2711
    • Erk, N.1
  • 11
    • 0344628593 scopus 로고    scopus 로고
    • An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets
    • Ertuerk, S., S. A. Esra, E. Lale, and F. Samiye. 2003. An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. J. Pharm. Biomed. Anal. 33: 1017-1023.
    • (2003) J. Pharm. Biomed. Anal , vol.33 , pp. 1017-1023
    • Ertuerk, S.1    Esra, S.A.2    Lale, E.3    Samiye, F.4
  • 12
    • 0042591788 scopus 로고    scopus 로고
    • Determination of atorvastatin calcium and its related substances by CZE
    • Feng, Y., L. Zhihe, W. Xuejun, J. Wenqing, and Z. Ding. 2003. Determination of atorvastatin calcium and its related substances by CZE. Zhongguo Yaoxue Zazhi 38: 456-458.
    • (2003) Zhongguo Yaoxue Zazhi , vol.38 , pp. 456-458
    • Feng, Y.1    Zhihe, L.2    Xuejun, W.3    Wenqing, J.4    Ding, Z.5
  • 13
    • 25444490990 scopus 로고    scopus 로고
    • Simultaneous determination of atorvastatin calcium and amlodipine besylate from pharmaceutical formulation by reversed phase high performance liquid chromatography
    • Freddy, H., and V. Chaudhari. 2005. Simultaneous determination of atorvastatin calcium and amlodipine besylate from pharmaceutical formulation by reversed phase high performance liquid chromatography. Asian J. Chem. 17: 2502-2508.
    • (2005) Asian J. Chem , vol.17 , pp. 2502-2508
    • Freddy, H.1    Chaudhari, V.2
  • 14
    • 34548129560 scopus 로고    scopus 로고
    • Liquid chromatography/negative ion electrospray tandem mass spectrometry method for the quantification of rosuvastatin in human plasma: Application to a pharmacokinetic study
    • Gao, J., D. Zhong, D. Xiaotao, and C. Xiaoyan. 2007. Liquid chromatography/negative ion electrospray tandem mass spectrometry method for the quantification of rosuvastatin in human plasma: Application to a pharmacokinetic study. J. Chromatogr. B 856: 35-40.
    • (2007) J. Chromatogr. B , vol.856 , pp. 35-40
    • Gao, J.1    Zhong, D.2    Xiaotao, D.3    Xiaoyan, C.4
  • 15
    • 0035947337 scopus 로고    scopus 로고
    • Chromatographic purification of some 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors
    • Grahek, R., D. Milivojevic, A. Bastarda, and M. Kracun. 2001. Chromatographic purification of some 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. J. Chromatogr. A 918: 319-324.
    • (2001) J. Chromatogr. A , vol.918 , pp. 319-324
    • Grahek, R.1    Milivojevic, D.2    Bastarda, A.3    Kracun, M.4
  • 16
    • 22144450683 scopus 로고    scopus 로고
    • Determination of atorvastatin and metabolites in human plasma with solid-phase extraction followed by LC-tandem MS
    • Hermann, M., H. Christensen, and J. L. B. Reubsaet. 2005. Determination of atorvastatin and metabolites in human plasma with solid-phase extraction followed by LC-tandem MS. Anal. Bioanal. Chem. 382: 1242-1249.
    • (2005) Anal. Bioanal. Chem , vol.382 , pp. 1242-1249
    • Hermann, M.1    Christensen, H.2    Reubsaet, J.L.B.3
  • 19
    • 33750145281 scopus 로고    scopus 로고
    • Simultaneous spectrophotometric determination of atorvastatin calcium and amlodipine besylate in tablets
    • Khan, M. R., and D. Jain. 2006. Simultaneous spectrophotometric determination of atorvastatin calcium and amlodipine besylate in tablets. Indian J. Pharm. Sci. 68: 546-548.
    • (2006) Indian J. Pharm. Sci , vol.68 , pp. 546-548
    • Khan, M.R.1    Jain, D.2
  • 22
    • 70449445163 scopus 로고    scopus 로고
    • Spectrophotometric methods for the determination of rosuvastatin calcium in pure form and in pharmaceutical formulations by using redox/complexation reactions
    • Krishna, M. V., and D. G. Sankar. 2006. Spectrophotometric methods for the determination of rosuvastatin calcium in pure form and in pharmaceutical formulations by using redox/complexation reactions. Pharm. Rev. 5: 164-166.
    • (2006) Pharm. Rev , vol.5 , pp. 164-166
    • Krishna, M.V.1    Sankar, D.G.2
  • 23
    • 33847768025 scopus 로고    scopus 로고
    • Extractive spectrophotometric methods for the determination of rosuvastatin calcium in pure form and in pharmaceutical formulations by using safranin O and methylene blue
    • Krishna, M. V., and D. G. Sankar. 2007. Extractive spectrophotometric methods for the determination of rosuvastatin calcium in pure form and in pharmaceutical formulations by using safranin O and methylene blue. E-J. Chem. 4: 46-49.
    • (2007) E-J. Chem , vol.4 , pp. 46-49
    • Krishna, M.V.1    Sankar, D.G.2
  • 24
    • 33748922625 scopus 로고    scopus 로고
    • Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies
    • Kumar, T. R., N. R. Shitut, P. K. Kumar, M. C. Vinu, V. V. Kumar, R. Mullangi, and N. R. Srinivas. 2006. Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies. Biomed. Chromatogr. 20: 881-887.
    • (2006) Biomed. Chromatogr , vol.20 , pp. 881-887
    • Kumar, T.R.1    Shitut, N.R.2    Kumar, P.K.3    Vinu, M.C.4    Kumar, V.V.5    Mullangi, R.6    Srinivas, N.R.7
  • 25
    • 34249935493 scopus 로고    scopus 로고
    • Quantitative determination of rosuvastatin in human plasma by ion pair liquid-liquid extraction using liquid chromatography with electrospray ionization tandem mass spectrometry
    • Lan, K., X. Jiang, Y. Li, L. Wang, J. Zhou, Q. Jiang, and L. Ye. 2007. Quantitative determination of rosuvastatin in human plasma by ion pair liquid-liquid extraction using liquid chromatography with electrospray ionization tandem mass spectrometry. J. Pharm. Biomed. Anal. 44: 540-546.
    • (2007) J. Pharm. Biomed. Anal , vol.44 , pp. 540-546
    • Lan, K.1    Jiang, X.2    Li, Y.3    Wang, L.4    Zhou, J.5    Jiang, Q.6    Ye, L.7
  • 26
    • 25444511109 scopus 로고    scopus 로고
    • Determination of rosuvastatin in the presence of its degradation products by a stabilityindicating LC method
    • Mehta, T. N., A. K. Patel, G. M. Kulkarni, and G. Suubbaiah. 2005. Determination of rosuvastatin in the presence of its degradation products by a stabilityindicating LC method. J. AOAC Int. 88: 1142-1147.
    • (2005) J. AOAC Int , vol.88 , pp. 1142-1147
    • Mehta, T.N.1    Patel, A.K.2    Kulkarni, G.M.3    Suubbaiah, G.4
  • 27
    • 33846450691 scopus 로고    scopus 로고
    • A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets
    • Mohammadi, A., N. Rezanour, A. Dogaheh, G. Bidkorbeh, M. Hashem, and R. B. Walker. 2007. A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets. J. Chromatogr. B 846: 215-221.
    • (2007) J. Chromatogr. B , vol.846 , pp. 215-221
    • Mohammadi, A.1    Rezanour, N.2    Dogaheh, A.3    Bidkorbeh, G.4    Hashem, M.5    Walker, R.B.6
  • 28
    • 33645883538 scopus 로고    scopus 로고
    • Liquid chromatography/negative ion electrospray tandem mass spectrometry method for the quantification of fluvastatin in human plasma: Validation and its application to pharmacokinetic studies. Rapid Commun
    • Nirogi, R. V. S., V. N. Kandikere, W. Shrivastava, K. Mudigonda, and P. V. Datla. 2006. Liquid chromatography/negative ion electrospray tandem mass spectrometry method for the quantification of fluvastatin in human plasma: Validation and its application to pharmacokinetic studies. Rapid Commun. Mass Spectrom. 20: 1225-1230.
    • (2006) Mass Spectrom , vol.20 , pp. 1225-1230
    • Nirogi, R.V.S.1    Kandikere, V.N.2    Shrivastava, W.3    Mudigonda, K.4    Datla, P.V.5
  • 29
    • 33747481284 scopus 로고    scopus 로고
    • Development of a selective LC method for the determination of pravastatin sodium
    • Onal, A., and O. Sagirli. 2006. Development of a selective LC method for the determination of pravastatin sodium. Chromatographia 64: 157-162.
    • (2006) Chromatographia , vol.64 , pp. 157-162
    • Onal, A.1    Sagirli, O.2
  • 30
    • 33644755513 scopus 로고    scopus 로고
    • Application of microbore HPLC in combination with tandem MS for the quantification of rosuvastatin in human plasma
    • Oudhoff, K. A., T. Sangster, E. Thomas, and I. D. Wilson. 2006. Application of microbore HPLC in combination with tandem MS for the quantification of rosuvastatin in human plasma. J. Chromatogr. B 832: 191-196.
    • (2006) J. Chromatogr. B , vol.832 , pp. 191-196
    • Oudhoff, K.A.1    Sangster, T.2    Thomas, E.3    Wilson, I.D.4
  • 31
    • 70449383977 scopus 로고    scopus 로고
    • Spectrophotometric determination of atorvastatin in pharmaceutical formulations
    • Prabhakar, B. K., M. Shobha, and R. S. Appala. 2005. Spectrophotometric determination of atorvastatin in pharmaceutical formulations. Int. J. Chem. Sci. 3: 37-40.
    • (2005) Int. J. Chem. Sci , vol.3 , pp. 37-40
    • Prabhakar, B.K.1    Shobha, M.2    Appala, R.S.3
  • 32
    • 70449445162 scopus 로고    scopus 로고
    • Reverse phase-high performance liquid chromatographic determination of atorvastatin calcium in solid dosage forms
    • Puratchikody, A., R. Valarmathy, S. P. Varghese, and J. J. Rukumani. 2003. Reverse phase-high performance liquid chromatographic determination of atorvastatin calcium in solid dosage forms. Pharm. Rev. 1: 79-83.
    • (2003) Pharm. Rev , vol.1 , pp. 79-83
    • Puratchikody, A.1    Valarmathy, R.2    Varghese, S.P.3    Rukumani, J.J.4
  • 33
    • 33745172785 scopus 로고    scopus 로고
    • RP-HPLC method for the simultaneous determination of atorvastatin and amlodipine in tablet dosage form
    • Rajeswari, K. R., G. G. Sankar, A. L. Rao, and J. V. L. N. Seshagirirao. 2006. RP-HPLC method for the simultaneous determination of atorvastatin and amlodipine in tablet dosage form. Indian J. Pharm. Sci. 68: 275-277.
    • (2006) Indian J. Pharm. Sci , vol.68 , pp. 275-277
    • Rajeswari, K.R.1    Sankar, G.G.2    Rao, A.L.3    Seshagirirao, J.V.L.N.4
  • 34
    • 33747162185 scopus 로고    scopus 로고
    • Simultaneous estimation of rosuvastatin and ezetimibe by reverse phase high performance liquid chromatography. Asian
    • Rajkondawar, V. V. 2006. Simultaneous estimation of rosuvastatin and ezetimibe by reverse phase high performance liquid chromatography. Asian J. Chem. 18: 3230-3232.
    • (2006) J. Chem , vol.18 , pp. 3230-3232
    • Rajkondawar, V.V.1
  • 35
    • 70449420953 scopus 로고    scopus 로고
    • Estimation of pravastatin sodium in tablets by HPLC
    • Rani, B. S., and P. V. Reddy. 2006. Estimation of pravastatin sodium in tablets by HPLC. Acta Cien. Indica. Chem. 32: 409-412.
    • (2006) Acta Cien. Indica. Chem , vol.32 , pp. 409-412
    • Rani, B.S.1    Reddy, P.V.2
  • 37
    • 70449430839 scopus 로고    scopus 로고
    • Selective spectrophotometric determination of atorvastatin. Mansoura
    • Salem, H., G. G. Ragab, A. E. Saif, and A. Aboul-Kheir. 2006. Selective spectrophotometric determination of atorvastatin. Mansoura J. Pharm. Sci. 22: 87-101.
    • (2006) J. Pharm. Sci , vol.22 , pp. 87-101
    • Salem, H.1    Ragab, G.G.2    Saif, A.E.3    Aboul-Kheir, A.4
  • 38
  • 39
  • 41
    • 58249142600 scopus 로고    scopus 로고
    • Application of UV-spectrophotometry and RP-HPLC for simultaneous determination of atorvastatin calcium and ezetimibe in pharmaceutical dosage form. Eurasian
    • Sonawane, S. S., A. A. Shirkhedkar, R. Fursule, and S. Sanjay. 2006. Application of UV-spectrophotometry and RP-HPLC for simultaneous determination of atorvastatin calcium and ezetimibe in pharmaceutical dosage form. Eurasian J. Anal. Chem. 1: 31-41.
    • (2006) J. Anal. Chem , vol.1 , pp. 31-41
    • Sonawane, S.S.1    Shirkhedkar, A.A.2    Fursule, R.3    Sanjay, S.4
  • 42
    • 34248231958 scopus 로고    scopus 로고
    • Validation of HPLC method for determination of atorvastatin in tablets and for monitoring stability in solid phase
    • Stanisz, B., and K. Lukasz. 2006. Validation of HPLC method for determination of atorvastatin in tablets and for monitoring stability in solid phase. Acta Pol. Pharm. 63: 471-476.
    • (2006) Acta Pol. Pharm , vol.63 , pp. 471-476
    • Stanisz, B.1    Lukasz, K.2
  • 43
    • 23944509308 scopus 로고    scopus 로고
    • Simultaneous determination of rosuvastatin and fenofibric acid in human plasma by LC-MS/MS with electrospray ionization: Assay development, validation, and application to a clinical study
    • Trivedi, R. K., R. R. Kallem, R. Mullagi, and N. R. Srinvas. 2005. Simultaneous determination of rosuvastatin and fenofibric acid in human plasma by LC-MS/MS with electrospray ionization: Assay development, validation, and application to a clinical study. J. Pharm. Biomed. Anal. 39: 661-669.
    • (2005) J. Pharm. Biomed. Anal , vol.39 , pp. 661-669
    • Trivedi, R.K.1    Kallem, R.R.2    Mullagi, R.3    Srinvas, N.R.4
  • 44
    • 33646915183 scopus 로고    scopus 로고
    • Column-switching high-performance liquid chromatographic analysis of fluvastatin in rat plasma by direct injection
    • Um, S. Y., S. H. Jung, S. J. Jung, J. I. Kim, S. Y. Chung, H. J. Lee, S. B. Han, and S. O. Choi. 2005. Column-switching high-performance liquid chromatographic analysis of fluvastatin in rat plasma by direct injection. J. Pharm. Biomed. Anal. 41: 1458-1462.
    • (2005) J. Pharm. Biomed. Anal , vol.41 , pp. 1458-1462
    • Um, S.Y.1    Jung, S.H.2    Jung, S.J.3    Kim, J.I.4    Chung, S.Y.5    Lee, H.J.6    Han, S.B.7    Choi, S.O.8
  • 45
    • 70449441987 scopus 로고    scopus 로고
    • United States Pharmacopeia. 3/ed., 2008. Rockville, MD: United States Pharmacopeia Convention
    • United States Pharmacopeia. 3/ed., 2008. Rockville, MD: United States Pharmacopeia Convention.
  • 46
    • 34250873333 scopus 로고    scopus 로고
    • Spectrophotometric determination of rosuvastatin calcium in tablets
    • Uyar, B., M. Celebier, and S. Altinoz. 2007. Spectrophotometric determination of rosuvastatin calcium in tablets. Pharmazie. 62: 411-413.
    • (2007) Pharmazie , vol.62 , pp. 411-413
    • Uyar, B.1    Celebier, M.2    Altinoz, S.3
  • 47
    • 33751074910 scopus 로고    scopus 로고
    • Simultaneous quantitation of rosuvastatin and gemfibrozil in human plasma by high-performance liquid chromatography and its application to a pharmacokinetic study
    • Vittal, S., R. S. Nikhil, T. R. Kumar, M. C. A. Vinu, R. Mullangi, and N. R. Srinivas. 2006. Simultaneous quantitation of rosuvastatin and gemfibrozil in human plasma by high-performance liquid chromatography and its application to a pharmacokinetic study. Biomed. Chromatogr. 20: 1252-1259.
    • (2006) Biomed. Chromatogr , vol.20 , pp. 1252-1259
    • Vittal, S.1    Nikhil, R.S.2    Kumar, T.R.3    Vinu, M.C.A.4    Mullangi, R.5    Srinivas, N.R.6
  • 48
    • 33747490726 scopus 로고    scopus 로고
    • Quantitative determination of rosuvastatin in human plasma by liquid chromatography with electrospray ionization tandem mass spectrometry. Rapid Commun
    • Xu, D., R. Zou-Rong, Q. Zhou, H. Yuan, and B. Jiang. 2006. Quantitative determination of rosuvastatin in human plasma by liquid chromatography with electrospray ionization tandem mass spectrometry. Rapid Commun. Mass Spectrom. 20: 2369-2375.
    • (2006) Mass Spectrom , vol.20 , pp. 2369-2375
    • Xu, D.1    Zou-Rong, R.2    Zhou, Q.3    Yuan, H.4    Jiang, B.5
  • 49
    • 23944514293 scopus 로고    scopus 로고
    • A simple and rapid HPLC method for the determination of atorvastatin in human plasma with UV detection and its application to pharmacokinetic studies
    • Zarghi, A., S. Alireza, F. S. Mohsen, and K. Arash. 2005. A simple and rapid HPLC method for the determination of atorvastatin in human plasma with UV detection and its application to pharmacokinetic studies. Arzneim. Forsch.55: 451-454.
    • (2005) Arzneim. Forsch , vol.55 , pp. 451-454
    • Zarghi, A.1    Alireza, S.2    Mohsen, F.S.3    Arash, K.4
  • 50
    • 0037419498 scopus 로고    scopus 로고
    • High-performance liquid chromatography coupled with negative ion tandem mass spectrometry for determination of pravastatin in human plasma
    • Zhu, Z., and L. Neirinck. 2003. High-performance liquid chromatography coupled with negative ion tandem mass spectrometry for determination of pravastatin in human plasma. J. Chromatogr. B 783: 133-140.
    • (2003) J. Chromatogr. B , vol.783 , pp. 133-140
    • Zhu, Z.1    Neirinck, L.2


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