Stability Indicating Spectrophotometric Methods Determination of Nicardipine in the Presence of its Alkaline Induced Degradation Products


  • Hayam Mahmoud Lotfy Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., P. O. Box 11562, Cairo, Egypt
  • Maha Abd El-monem Hegazy
  • Mai M. Abd El-aziz
  • Laila Elsayed Abdel Fattah


Objective: Derivative, ratio spectra derivative and ratio difference spectrophotometric methods were developed and validated for simultaneous determination of Nicardipine (NIC) in the presence of its alkaline induced degradation products.

Methods: In these methods the overlapped spectra of NIC and its alkaline induced degradation products were well resolved by measuring the amplitudes of first derivative (D1) spectra and the second derivative (D2) at 382.3 and 239 nm, respectively. NIC was determined by ratio spectra derivative by measuring the amplitude at 244 nm. The ratio difference spectrophotometric method was developed in which the difference between amplitudes at 237.5 nm and 260 nm of the ratio spectra were recorded. The linearity range for the applied methods was 2-18 μg/ml.

Results: All the developed methods were validated according to ICH Guidelines, NIC was determined with acceptable accuracy and precision.

Conclusion: These methods were suitable as stability indicating methods for the determination of NIC in the presence of its alkaline induced degradation products either in bulk powder or in a pharmaceutical formulation. Statistical analysis of the results with those obtained by applying a reported method has been carried out revealing high accuracy and good precision.

Keywords: Nicardipine, Spectrophotometry, Pharmaceutical preparations, Stability indicating, derivative, ratio derivative and ratio difference


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Budavari, Susan. In: Merk Index. 12 th ed. Merk and Co. New York; 1996.

Parfitt K. In: Martindal, The Complete Drug Reference. 32nd ed. The Pharmaceutical Press: Massachusts; 1999. p. 915.

Escrig-Tena I, Alvarez Rodríguez L, Esteve-Romero J, García-Alvarez-Coque MC. Micellar modified the spectrophotometric determination of nitrobenzenes based upon reduction with tin(II), diazotisation and coupling with the bratton-marshall reagent. Talanta 1998;47:43-52.

Ragno G, Vetuschi C, Risoli A, Ioele G. Application of a classical least-squares regression method to the assay of 1,4-dihydropyridine antihypertensives and their photoproducts. Talanta 2003;59:375-82.

Marciniec B, Ogrodowczyk M. Thermal stability of 1, 4-dihydropyridine derivatives in solid state. Acta Pol Pharm 2006; 63:477-84.

Al-Ghannam SM, Al-Olyan AM. Spectrofluorometric determination of nicardipine, nifedipine and isradipine in pharmaceutical preparations and biological fluids. J Central Eur Chem 2008;6:222-8.

Obendorf D, Stubauer G. Adsorptive stripping voltammetry of NIC at a HMDE; determination of trace levels NIC in blood and urine. J Pharm Biomed Anal 1995;13:1339-41.

Uno T, Ohkubo T, Sugawara K. Enantioselective high-performance liquid chromatographic determination of NIC in human plasma. J Chromatogr B: Biomed Sci Appl 1997;698:181-6.

López JA, Martínez V, Alonso RM, Jiménez RM. High-performance liquid chromatography with amperometric detection applied to the screening of 1,4-dihydropyridines in human plasma detection applied to the screening of 1,4-dihydropyridines in human plasma. J Chromatogr A 2000;870:105-14.

Fernandes CM, Veiga FJ. A simple method for NIC quantification in plasma using solid-phase extraction and reversed-phase high-performance liquid chromatography. Biomed Chromatogr 2003;17:33-8.

Miling Q, Wang P, Xin J. Liquid chromatography-mass spectrometry method for the determination of NIC in human plasma. J Chromatogr B: Biomed Sci Appl 2006;830:81-5.

Bakhtiar R, Tse FL. High-throughput chiral liquid chroma-tography/tandem mass spectrometry. Rapid Commun 2000;14:1128-35.

Chen SM, Hsieh MC, Chao SH, Chang EE, Wang PY, Wu AB. Separation and structure determination of NIC photo products by LC-ESI-MS. Biomed Chromatogr 2008;22:1008-12.

Pomponio R, Gotti R, Fiori J, Cavrini V, Mura P, Cirri M, Maestrelli F. Photostability studies on NIC-cyclodextrin complexes by capillary electrophoresis. J Pharm Biomed Anal 2004;35:267-75.

Teraoka R, Otsuka M, Matsuda Y. Evaluation of photostability of solid-state NIC polymorphs by using fourier-transformed reflection-absorption infrared spectroscopy-effect of grinding on the photostability of crystal form. Int J Pharm 2004;286:1-8.

Ibrahim KE, Al-Ashban RM, Babikers LB. A selective high performance liquid chromatographic method to follow the hydrolytic degradation of NIC. E J Chem 2010;7:85-92.

International Conference on Harmonization (ICH), Q2 (R1) Validation of Analytical Procedures: Text and Methodology, ICH Harmonized Triapartite Guideline; 2005.

Lotfy H, Hegazy MA, Rezk MR, Omran YR. Novel spectro-photometric methods for simultaneous determination of timolol and dorzolamide in their binary mixture. Spectrochim Acta Part A 2012;96:259-70.



How to Cite

Lotfy, H. M., M. A. E.- monem Hegazy, M. M. Abd El-aziz, and L. E. A. Fattah. “Stability Indicating Spectrophotometric Methods Determination of Nicardipine in the Presence of Its Alkaline Induced Degradation Products”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, no. 3, Mar. 2016, pp. 62-66,



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