Development and validation of stability-indicating high-performance thin-layer chromatography method for estimation of ciprofibrate in bulk and in pharmaceutical formulation

• Autorzy: Jain P. S , Jivani H. N , Khatal R. N , Surana S. J.
• Języki publikacji: EN

Abstrakty

EN

A simple, selective, precise, and stability-indicating high-performance thinlayer chromatography (HPTLC) method for the analysis of ciprofibrate both in bulk drug and pharmaceutical formulation has been developed and validated. The method employed HPTLC aluminum plates precoated with silica gel 60 RP-18 F254 as the stationary phase. The solvent system consisted of methanol-water-triethylamine (2.8:2.2:0.2 υ/υ). The system was found to give compact spot for ciprofibrate (RF value of 0.55 ± 0.02). Densitometric analysis of ciprofibrate was carried out in the absorbance mode at 232 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.998 ± 0.0015 with respect to peak area in the concentration range 600–1600 ng per spot. The mean values ± SD of slope and intercept were 3.38 ± 1.47 and 986.9 ± 108.78, respectively, with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 17.84 and 54.08 ng per spot, respectively. Ciprofibrate was subjected to acid and alkali hydrolysis, oxidation, and thermal degradation. The drug undergoes degradation under acidic and basic conditions. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved from the pure drug with significantly different RF value. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of ciprofibrate in bulk drug and pharmaceutical formulation.

Słowa kluczowe

EN

ciprofibrate; high-performance thin-layer chromatography (HPTLC); validation; stability; degradation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2011
• Tom: Vol. 23, no. 3
• Strony: 469--482
• Opis fizyczny: Bibliogr. 13 poz., rys., tab.

Twórcy

autor

Jain P. S

• R. C. Patel Institute of Pharmaceutical Education and Research Karwand Naka, Shirpur Dist. Dhule 425 405 M.S. India

autor

Jivani H. N

• R. C. Patel Institute of Pharmaceutical Education and Research Karwand Naka, Shirpur Dist. Dhule 425 405 M.S. India

autor

Khatal R. N

• R. C. Patel Institute of Pharmaceutical Education and Research Karwand Naka, Shirpur Dist. Dhule 425 405 M.S. India

autor

Surana S. J.

• R. C. Patel Institute of Pharmaceutical Education and Research Karwand Naka, Shirpur Dist. Dhule 425 405 M.S. India

Bibliografia

• [1] Martindale: The Complete Drug Reference, 35th edn, Council of Royal Pharmaceutical Society of Great Britain, 2007, pp. 1118–1119
• [2] S. Budavari, The Merck Index, 14th edn, Merck and Co., White House Station, New Jersey, 1996, p. 386
• [3] Goodman and Gilman’s: The Pharmacological Basis of Therapeutics, 10th edn, McGraw-Hill, New York, 2003–2004, pp. 971–1002
• [4] British Pharmacopoeia, Medicinal and Pharmaceutical Substances (A-I), The Stationery Office, London, 2005, vol. 1, pp. 106–108
• [5] E.G.B. Bighetti, P.R. Patricio, A.C. Casquero, J.A. Berti, and H.C.F. Oliveira, Lipids Health Dis., 50(8), 1–9 (2009)
• [6] G. Misztal and L. Komsta, J. Planar Chromatogr., 18(3), 188–193 (2005)
• [7] L.D. Masnatta, L. A. Cuniberti, R.H. Rey, and J. Werba, J. Chromatogr. B, 687(2), 437–442 (1996)
• [8] N.H. Anderson, D. Johnston, and P.R. Vojvodic, J. Pharm. Biomed. Anal., 10(7), 501–505 (1992)
• [9] H. Huttemann and G. Blaschke, J. Chromatogr. B, 729(1–2), 33–41 (1999)
• [10] P.D. Sethi, High Performance Thin Layer Chromatography: Quantitative Analysis of Pharmaceutical Formulations, CBS, New Delhi, 1996, pp. 162–165
• [11] M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011–1040 (2002)
• [12] ICH, Q2A text on validation of analytical procedures, International Conference on Harmonization, Geneva, October 1994
• [13] ICH, Q3B validation of analytical procedures: methodology, International Conference on Harmonization, Geneva, November 1996