2014, Number 4
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Rev Invest Clin 2014; 66 (4)
Pioglitazone hydrochloride a instrumental analytical perspective by Raman spectroscopy and HPLC
Vértiz-Beltrán JF, Ávila-Rodríguez R, Terrones-Gurrola R, Camacho LA, Rangel-López A, Campos-Cantón I, Vértiz-Hernández ÁA
Language: Spanish
References: 24
Page: 351-358
PDF size: 180.71 Kb.
ABSTRACT
Introduction. The thiazolidinediones (pioglitazone) increases
the action of insulin and produces the glycemic
control in the patients with type 2 diabetes mellitus. Also,
the pharmacological effect may be affected by the purity and
pioglitazone plasma concentration. Therefore, the instrumental
techniques offer a tool for characterization, identification
and/or quantification of the pioglitazone; Raman
spectroscopy offers several advantages due to its easy application
methodology and structural analysis and the HPLC
technique is the gold standard vs. other qualitative and
quantitative techniques.
Objective. The aim of this work is
to develop and validate analytical techniques for the characterization
of pioglitazone hydrochloride by Raman spectroscopy
and quantitative analysis in human plasma by HPLC.
Material and methods. The pioglitazone hydrochloride
was analyzed by Raman spectroscopy with a 678 mW power
and 3 integration time seconds. The analytical method for
quantification by HPLC was validated with the guidelines
of the NOM-177SSA1-1998.
Results. The Raman
technique allowed us to elucidate the functional groups of
the pioglitazone hydrochloride and the HPLC technique was
linear, accurate, precise, specific and sensitive in the range
of 30 to 2,000 ng/mL under the chromatographic conditions
specified.
Conclusions. The structure analysis by Raman
spectroscopy allowed us a complete characterization of the
functional groups of pioglitazone hydrochloride effectively
and non-destructively. Likewise, the analytical technique for
the pioglitazone hydrochloride quantification by HPLC was
linear, accurate, precise and sensitive in the range of 30 to
2,000 ng/mL under the guidelines.
REFERENCES
Carretero M. Pioglitazona; Monoterapia oral en pacientes con diabetes mellitus tipo 2. Actualidad científica 2005; 24(2): 112-4.
Norris SL, Lee NJ, Severance S, Thakurta S, Chan B. Drug Class review Thiazolidinediones. Oregon: Health & Science University (inedited); 2008, p. 5-7.
Colthup NB, Wiberly SE, Daly LH. Introduction to infrared and Raman spectroscopy. En: Flórez J, Armijo JA, África M. Farmacología Humana. Barcelona: Masson; 2005, p. 54.
Larkin PJ. Infrared and Raman spectroscopy, Principles and spectral interpretation. Massachusetts: Elsevier; 2007; 1-2. (A) 81, (B) 94, (C) 104, (D) 74, (E) 205, (F) 100, (G) 113, (D) 82, (I) 76, (D).
Medina Valtierra J, Sato Berrú RY, Frausto Reyes C. La espectroscopia Raman molecular y su aplicación ambiental. Conciencia Tecnológica 2003; 23.
Skoog DA, West DM, Holler FJ, Crouch SR. Fundamentos de química analítica. México: Thompson; 2005, p. 988-1006.
Medina-Valtierra J, Sato-Berru M, Frauto-Reyes. La espectroscopía molecular Raman y su aplicación ambiental. Conciencia Tecnológica 2006; 23: 4-5.
Douda J, Calva PA, Torchynska TV. Marcadores cuánticos para la detección de cancer revisión. Superficies y vacío 2008; 21(4): 10-7.
Ling XF, Xu YZ, Weng SF, Li WH, Zhi XU, Hammaker RM, et al. Investigation of normal and malignant tissue sample from the human stomach using fourier transform Raman Spectroscopy Appl. Spectrosc 2002; 56: 570-3.
Cervantes-Contreras M, Pedroza-Rodríguez AM. El pulque: características microbiológicas y contenido alcohólico mediante espectroscopia Raman. Superficies y vacío 2008; 20(3): 1-5.
Sato-Berrú RY, Medina-Gutiérrez C, Medina-Valtierra J, Frausto-Reyes C. Aplicación de la Espectroscopia Raman para la caracterización de pesticidas orgánicos. Revista Internacional de Contaminación Ambiental 2004; 20: 1.
Strachan CJ, Rades T, Gordon KC, Rantanen J. Raman spectroscopy for quantitative analysis of pharmaceutical solids”. J Pharm Pharmacol 2007; (2): 179-92.
Chieng N, Rehder S, Saville D, Rades T, Aaltonen J. Quantitative solid-state analysis of three solid forms of ranitidine hydrochloride in ternary mixtures using Raman spectroscopy and X-ray powder diffraction. J Pharm Biomed Anal 2008; 49(1): 18-25. Doi: 10.1016/j.jpba. 2008.09.054.
Heinz A, Savolainen M, Rades T, Strachan CJ. Quantifying ternary mixtures of different solid-state forms of indomethacin by Raman and near-infrared spectroscopy. Eur J Pharm Sci 2007; 3: 182-92.
Mazurek S, Szostak R. Quantitative determination of diclofenac sodium and aminophylline in injection solutions by FT-Raman spectroscopy. J Pharm Biomed Anal 2006; 40(5): 1235-42.
Mazurek S, Szostak R. Quantitative determination of captopril and prednisolone in tablets by FT-Raman spectroscopy. J Pharm Biomed Anal 2006; 40(5): 1225-30.
Li SX, Chen QY, Zhang YJ, Liu ZM, Xiong HL, Guo ZY, Mai HQ, et al. Detection of nasopharyngeal cancer using confocal Raman spectroscopy and genetic algorithm technique. J Biomed 2012; Opt 17: 12: 125003.
Lattermann A, Matthäus C, Bergner N, Beleites C, Romeike BF, Krafft C, Brehm BR, et al. Characterization of atherosclerotic plaque depositions by Raman and FTIR imaging. J Biophotonics 2013; 6(1): 110-21.
Pattana S, Penporn N, Aurasorn S. High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study. J Chromatography B 2006; 843: 164-9.
Sideroudi T, Pharmakakis N, Papatheodorou G, Voyiatzis G. Non-invasive detection of antibiotics and physiological substances in the aqueous humor by Raman spectroscopy. Lasers Surg Med 2006; 38(7): 695-703.
Kolte BL, Raut BB, Deo AA, Bagool MA, Shinde DB. Simultaneous high-performance liquid chromatographic determination of pioglitazone and metformin in pharmaceutical-dosage form. J Chromatogr 2004; 42: 27-31.
Zhong WZ, Williams MG. Simultaneous quantitation of pioglitazone and its metabolites in human serum by liquid chromatography and solid phase extraction. Elsevier Science 2003; 14: 465-73.
Norma Oficial Mexicana NOM-177-SSA1-1998, Que establece las pruebas y procedimientos para demostrar que un medicamento es intercambiable. Requisitos a que deben sujetarse los terceros autorizados que realicen las pruebas. Disponible en http://www.google.com.mx. consultado en Noviembre 11, 2013.
Center for Drug Evaluation and Research (CDER). Disponible en: http://www.fda.gov/CDER/GUIDANCE/cmc3.pdf