Powiadomienia systemowe
- Sesja wygasła!
Tytuł artykułu
Autorzy
Wybrane pełne teksty z tego czasopisma
Identyfikatory
Warianty tytułu
Języki publikacji
Abstrakty
A simple, specific, sensitive, precise, accurate, and robust stability-indicating reversed-phase liquid chromatographic (LC) method has been established for analysis of pitavastatin calcium in tablet dosage forms. LC separation was achieved on a 250 mm × 4.6 mm i.d., 5-μm particle, C18 column with acetonitrile-water-triethylamine 80:19.8:0.2 (υ/υ), adjusted to pH 3.5 ± 0.05 with orthophosphoric acid as isocratic mobile phase at a flow rate of 1.5 mL min-1. Detection, with a photodiode-array detector, was at 238 nm, the wavelength of maximum absorbance in a spectrum obtained from its solution in methanol. The retention time was approximately 5.70 min. The method was validated for linearity, accuracy, precision, limits of detection and quantification, and robustness. Quantification was performed over the concentration range 0.1–2.5 μg mL-1. Mean recovery was 100.26 ± 0.75%. The limit of detection (LOD) was 0.0055 µg mL-1. The method was successfully used for analysis of pitavastatin calcium in tablets and for stability studies, because the method separates pitavastatin calcium from its degradation products and from excipients.
Czasopismo
Rocznik
Tom
Strony
81--94
Opis fizyczny
Bibliogr. 16 poz., rys., tab.
Twórcy
autor
- Shree S.K. Patel College of Pharmaceutical Education and Research Ganpat Vidyanagar, Kherva Mehsana 382711 Gujarat India
autor
- L.M. College of Pharmacy Department of Pharmaceutical Chemistry Navrangpura, Ahmedabad 380009 Gujarat India
Bibliografia
- [1] M. Soyka, C. Schuetz, and U. Preuss, Drugs in R & D, 3, 58–60 (2002)
- [2] Martindale: The Complete Drug Reference, 35th edn, Pharmaceutical Press, London, 2007, pp. 1234
- [3] Remington: The Science and Practice of Pharmacy, 21st edn, Lippincott Williams & Wilkins, New York, 2006, pp. 1368
- [4] L. Rosa and C. John, Amer. J. Cardiovasc. Drugs, 3, 271–281 (2003)
- [5] K. Kalinami, N. Takekoshi, and Y. Saito, Cardiovasc. Drug Rev., 21, 199–215 (2003)
- [6] The Merck Index, 14th edn, Merck Research Laboratories, Division of Merck and Co. Inc., Whitehouse Station, NJ, 2006, pp. 1294–1295
- [7] M.V. Krishna and D.G. Sankar, Eurasian J. Chem., 4, 272–278 (2007)
- [8] Y. Katsuta, M. Ohsuga, H. Komeichi, S. Shimizu, Y. Kato, A. Miyamoto, K. Satomura, and H. Tetada, Jap. Pharmacol. Ther., 35, 489–501 (2007)
- [9] N.K. Satheesh and J. Baghyalakshmi, Anal. Lett., 40, 2625–2632 (2007)
- [10] J. Kojima, H. Fujino, M. Yosimura, H. Morikawa, and H. Kimata, J. Chromatogr. B, 724, 173–180 (1999)
- [11] N. Ramakrishna, M. Koteshwara, and K. Vishwottam, J. Pharm. Biomed. Anal., 44, 379–387 (2007)
- [12] W.D. Jian, B.K. Kwon, H.Z. Hong, H.L. Kwang, and G.S. Jae, Biomed. Chromatogr., 22, 131–135 (2007)
- [13] L. Hua, G.S. Jian, J.W. Guang, Y.Z. Xiao, Z. Ying, H.G. Sheng, L. Yan, and S. Jie, Clin. Chim. Acta, 386, 25–30 (2007)
- [14] Stability testing of new drug substances and products Q1(AR), International Conference on Harmonization (ICH), Geneva, 2000
- [15] S. Singh and M. Bakshi, Pharm. Technol., 24, 1–14 (2000)
- [16] Validation of Analytical Procedure: Text and Methodology Q2(R1), International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, 2005
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-5edc298a-03e5-4d8f-adc0-9a2fc7d1796e