, Volume 69, Issue 11–12, pp 1201–1209 | Cite as

Stability-Indicating LC Method for the Determination of Lacidipine in Tablets. Application to Degradation Kinetics and Content Uniformity Testing

  • Fathalla Belal
  • Amina Elbrashy
  • Manal Eid
  • Jenny Jeehan Nasr


A simple, stability-indicating, reversed-phase liquid chromatographic method was developed for the determination of lacidipine in the presence of its degradation products. The analysis was carried out using a 150 mm × 4.6 mm i.d., 5 μm particle size Nucleodur MN-C18 column. Mobile phase containing a mixture of acetonitrile and 0.02 M phosphate buffer (70:30) at pH = 5.0 was pumped at a flow rate of 1 mL min−1 with UV-detection at 254 nm. The method showed good linearity in the range of 0.06–15 μg mL−1 with a limit of detection (S/N = 3) of 0.016 μg mL−1 (3.5 × 10−8 M). The suggested method was successfully applied for the analysis of lacidipine in bulk and in commercial tablets with average recoveries of 100.19 ± 0.81% and 100.05 ± 0.69%, respectively. The results were favorably compared to those obtained by a reference method. The suggested method was utilized to investigate the kinetics of alkaline, acidic, peroxide and photo-induced degradation of the drug. The apparent first-order rate constant, half-life times and activation energies of the degradation process were calculated. The pH profile curve was derived. The proposed method was successfully applied to the content uniformity testing of tablets.


Column liquid chromatographic Content uniformity testing Stability-indicating and degradation-kinetics Lacidipine 


  1. 1.
    Sweetman S (2006) Martindale: The complete drug reference. (ed) Pharmaceutical Press. Electronic version, LondonGoogle Scholar
  2. 2.
    Tcherdakoff P (1995) J Cardiovasc Pharmacol 25(3):S27–S32Google Scholar
  3. 3.
    Lee CR, Bryson HM (1994) Drugs 48:274–296. doi: 10.2165/00003495-199448020-00010 CrossRefGoogle Scholar
  4. 4.
    Ravichandran V, Raghuraman S, Sankar V, Kalaiselvan V, Dharuman J, Dharamsi A (2004) Indian J Pharm Sci 66:797–799Google Scholar
  5. 5.
    Meyyanathan SN, Tresa Tonio M, Rama Sarma GVS, Suresh B (1999) IDrugs 36:572–575Google Scholar
  6. 6.
    Sagar GV (2003) Acta Cienc Indica Chem 30:45Google Scholar
  7. 7.
    Sagar GV, Rao NVSG, Sastry BS (2003) J Inst Chem Ind 75:170–172Google Scholar
  8. 8.
    Sagar GV, Sastry BS, Sagar BSH (2003) J Inst Chem Ind 75:133–134Google Scholar
  9. 9.
    Kharat VR, Verma KK, Dhake JD (2002) J Pharm Biomed Anal 28(3-4):789–793. doi: 10.1016/S0731-7085(01)00584-2 CrossRefGoogle Scholar
  10. 10.
    Ozkan SA (2002) Pharmazie 57:503–505Google Scholar
  11. 11.
    Squella JA, Iribarrean AE, Strum JC, Nunez-Vergara LJ (1999) J AOAC Int 82:1077–1082Google Scholar
  12. 12.
    Nozal MJ, Bernal JL, Jimenez JJ, Martin MT, Diez FJ (2004) J Chromatogr A 1024(1-2):115–122. doi: 10.1016/j.chroma.2003.10.064 CrossRefGoogle Scholar
  13. 13.
    Ren BY, Zhao BQ, Lin ZQ (1997) Chin Pharm J 32:764–765Google Scholar
  14. 14.
    Dinc E, Ragno G, Ioele G, Baleanu D (2006) J AOAC Int 89:1538–1546Google Scholar
  15. 15.
    Ragno G, Ioele G, Deluca M, Garofalo A, Grande F, Risoli A (2006) J Pharm Biomed Anal 42(1):39–45. doi: 10.1016/j.jpba.2005.11.025 CrossRefGoogle Scholar
  16. 16.
    De Filippis P, Bovina E, Da Ros L, Fiori J, Cavrini V (2002) J Pharm Biomed Anal 27(5):803–812. doi: 10.1016/S0731-7085(01)00505- CrossRefGoogle Scholar
  17. 17.
    Martínez V, López JA, Alonso RM, Jiménez RM (1999) J Chromatogr A 836:189–199. doi: 10.1016/S0021-9673(98)01029-2 CrossRefGoogle Scholar
  18. 18.
    Baranda AB, Jiménez RM, Alonso RM (2004) J Chromatogr A 1031:275–280. doi: 10.1016/j.chroma.2003.11.019 CrossRefGoogle Scholar
  19. 19.
    López JA, Martínez V, Alonso RM, Jiménez RM (2000) J Chromatogr A 870:105–114. doi: 10.1016/S0021-9673(99)01070-5 CrossRefGoogle Scholar
  20. 20.
    Baranda AB, Alonso RM, Jiménez RM, Weinmann W (2006) Forensic Sci Int 156:23–34. doi: 10.1016/j.forsciint.2004.11.014 CrossRefGoogle Scholar
  21. 21.
    Baranda AB, Mueller CA, Alonso RM, Jiménez RM, Weinmann W (2005) Ther Drug Monit 27(1):44–52. doi: 10.1097/00007691-200502000-00010 CrossRefGoogle Scholar
  22. 22.
    Baranda AB, Berasaluce O, Jiménez RM, Alonso RM (2005) Chromatographia 61(9-10):447–453. doi: 10.1365/s10337-005-0535-6 CrossRefGoogle Scholar
  23. 23.
    Baranda AB, Etxebarria N, Jiménez RM, Alonso RM (2005) J Chromatogr Sci 43:505–512Google Scholar
  24. 24.
    Baranda AB, Etxebarria N, Jiménez RM, Alonso RM (2005) Talanta 67:933–941. doi: 10.1016/j.talanta.2005.04.028 CrossRefGoogle Scholar
  25. 25.
    ICH Q1A(R2) (2003) Stability testing of new drug substances and products. International conference on harmonization, IFPMA, GenevaGoogle Scholar
  26. 26.
    Sinko PJ, Martin AN (2005) Martin’s physical pharmacy and pharmaceutical sciences: physical, chemical and biopharmaceutical principles in the pharmaceutical science, 5th edn. Lippincott Williams & Wilkins, Philadelphia, p 216, 397Google Scholar
  27. 27.
    The United States Pharmacopeia 30 (2007) The National Formulary 25, US pharmacopeial convention: Rockville, MD, Electronic versionGoogle Scholar
  28. 28.
    Miller JC, Miller JN (1993) Statistics for analytical chemistry, 4th edn. Ellis-Howood, New York, p 115Google Scholar
  29. 29.
    ICH Q2(R1) (2005) Validation of analytical procedures: text and methodology, International conference on harmonization, GenevaGoogle Scholar
  30. 30.
    Conners KA, Amidon GL, Kennon L (1979) In chemical stability of pharmaceuticals. John Wiley & sons, New York, p 20Google Scholar
  31. 31.
    Caulcut R, Boddy R (1983) Statistics for analytical chemists. Chapman & Hall, LondonGoogle Scholar

Copyright information

© Vieweg+Teubner | GWV Fachverlage GmbH 2009

Authors and Affiliations

  • Fathalla Belal
    • 1
  • Amina Elbrashy
    • 1
  • Manal Eid
    • 1
  • Jenny Jeehan Nasr
    • 1
  1. 1.Department of Analytical Chemistry, Faculty of PharmacyUniversity of MansouraMansouraEgypt

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