Kinetic Spectrophotometric Determination of Ramipril in Commercial Dosage Forms
This paper presents a simple and sensitive kinetic
spectrophotometric method for the determination of ramipril in
commercial dosage forms. The method is based on the reaction of the
drug with 1-chloro-2,4-dinitrobenzene (CDNB) in dimethylsulfoxide
(DMSO) at 100 ± 1ºC. The reaction is followed
spectrophotometrically by measuring the rate of change of the
absorbance at 420 nm. Fixed-time (ΔA) and equilibrium methods are
adopted for constructing the calibration curves. Both the calibration
curves were found to be linear over the concentration ranges 20 - 220
μg/ml. The regression analysis of calibration data yielded the linear
equations: Δ A = 6.30 × 10-4 + 1.54 × 10-3 C and A = 3.62 × 10-4 +
6.35 × 10-3 C for fixed time (Δ A) and equilibrium methods,
respectively. The limits of detection (LOD) for fixed time and
equilibrium methods are 1.47 and 1.05 μg/ml, respectively. The
method has been successfully applied to the determination of ramipril
in commercial dosage forms. Statistical comparison of the results
shows that there is no significant difference between the proposed
methods and Abdellatef-s spectrophotometric method.
[1] D. N. Franz, "Cardiovascular Drugs (Ed: A. R. Gennaro)," in
Remington: The Science and Practice of Pharmacy, 19th ed., Vol. II,
Mack Publishing Company, Pennsylvania, 1995, p. 951.
[2] T.G. Warner and M. C. Perry, "Ramipril: a review of its use in the
prevention of cardiovascular outcomes," Drugs, vol. 62, pp.1381-1405,
2002.
[3] Royal Pharmaceutical Society, "British Pharmacopoeia," vol. II, H. M.
Stationery Office, Royal Pharmaceutical Society, London, UK, 2000,
pp.1331-1333.
[4] Z. Zhimeng, V. Andre and N. Len, "Liquid chromatography-mass
spectrometry method for determination of ramipril and its active
metabolite ramiprilat in human plasma," J. Chromatography B., vol.
779, pp. 297-306, 2002.
[5] B. Francesco, M. Patrizia and Q. Fabiasa, "Analysis of ACE inhibtor
drugs by high performance liquid chromatography," Il Farmaco, vol. 49,
pp. 457-460, 1994.
[6] U. J. Dhorda and N. B. Shetkar, "RP-HPLC determination of ramipril
and amlodipine in tablets," Indian Drugs, vol. 36, pp. 638-641, 1999.
[7] S. S. Zarapakar and S. H. Rane, "RP-HPLC determination of ramipril
and hydrochlorothiazide in tablets," Indian Drugs, vol. 37, pp. 589-593,
2000.
[8] J. N. Harlikar and A. M. Amlani, "Simultaneous determination of
perindopril, indapamide, ramipril, trandapril in pharmaceutical
formulations using RP- HPLC," Res. J. Chem. Environ., vol. 7, pp. 59-
62, 2003.
[9] S. Hillaer, K. De Grauwe and W. Van den Bossche, "Simultaneous
determination of hydrochlorothiazide and several inhibitors of
angiotensin-converting enzyme by capillary electrophoresis,"
J.Chromatogr. A, vol. 924, pp. 439- 449, 2001.
[10] H. E. Abdellatef, M. M. Ayad and E. A. Taha, "Spectrophotometric and
atomic absorption spectrophotometric determination of ramipril and
perindopril through ternary complex formation with eosin and Cu (II),"
J. Pharm. Biomed. Anal., Vol. 18, pp. 1021-1027, 1999.
[11] M. M. Ayad, A. A. Shalaby, H. E. Abdellatef and M. M. Hosny,
"Spectrophotometric and AAS determination of ramipril and enalapril
through ternary complex formation," J. Pharm. Biomed. Anal., vol. 28,
pp. 311-321, 2002.
[12] J. A. Prieto, R. M. Jimenez and R. M. Alonso, "Square wave
voltammetric determination of angiotensin- converting enzyme
inhibitors cilazapril, quinapril and ramipril in pharmaceutical
formulation," Il Farmaco, vol. 58, pp. 343-350, 2003.
[13] H. Y. Aboul-Enein, R. I. Stefen and J. F. Van Staden, "Analysis of
several angiotensin-converting enzyme inhibitors using potentiometric,
enantioselective membrane electrodes," Anal. Lett., vol. 32, pp. 623-632,
1999.
[14] H. G. Eckert, G. Muenscher, R. Oekonomopulos, H. Strecker, H. Urbach
and H. A. Wissmann, "Radioimmunoassay for the II angiotensinconverting
enzyme inhibitor ramipril and its active metabolite,"
Arzneim.-Forsch, vol. 35, pp.1251-1256, 1985.
[15] H. H. Abdine, F. A. El-Yazbi, R. A. Shaalan and S. M.Blaih, "Direct
differential solubility and compensatory- derivative spectrophotometric
methods for resolving and subsequently determining binary mixtures of
some anti hypertensive drugs," S. T. P. Pharm Sci., vol. 9, pp.587-591,
1999.
[16] H. Salem, "Derivative spectrophotometric determination of two
component mixtures," Chin. Pharm. J., vol. 51, pp. 123-142, 1999.
[17] N. Erk, "Ratio-spectra-zero-crossing derivative spectrophotometric
determination of certain drugs in two component mixtures," Anal. Lett.,
vol. 32, pp. 1371-1388, 1999.
[18] S.M. Blaih, H. H. Abdine, F. A. El-Yazbi and R. A. Shaalan,
"Spectrophotometric determination of enalapril maleate and ramipril in
dosage forms," Spectrosc. Lett., vol. 33, pp. 91-102, 2000.
[19] F. M. Salama, O. I. A. El-Sattar, N. M. El-Aba Sawy and M.M. Fuad,
"Spectrophotometric determination of some ACE inhibitors through
charge transfer complexes," Al Azhar J. Pharm. Sci., vol. 27, pp. 121-
132, 2001.
[20] A. A. Al-Majed, F. Belal and A. A. Al-Warthan, "Spectrophotometric
determination of ramipril (a novel ACE inhibitor) in dosage forms,"
Spectrosc. Lett., vol. 34, pp. 211-220, 2001.
[21] A. A. Al-Majed and J. Al-Zehouri, "Use of 7- fluoro-4-nitrobenzo-2-
oxo-1,3-diazole for the determination of ramipril in tablet and spiked
human plasma," Il Farmaco, vol. 56, pp. 291-296, 2001.
[22] N. Rahman, Y. Ahmad and S. N. H. Azmi, "Kinetic spectrophotometric
method for the determination of ramipril in pharmaceutical
formulations," A. A. P. S. PharmSciTech., vol.6, pp. 543-551, 2005.
[23] J. Ermer, "Validation in pharmaceutical analysis. Part I: An integrated
approach.," J. Pharm. Biomed. Anal., vol. 24, pp.755-767, 2001.
[24] H. E. Bent and C. L. French, "The structure of ferric thiocyanate and its
dissociation in aqueous solution," J. Am. Chem. Soc., vol. 63, pp. 568-
572, 1941.
[25] E. Buncell, A. R. Norris and K. E. Russell, "The interaction of aromatic
nitro compounds with bases," Q. Rev. Chem. Soc., vol. 22, pp.123-125,
1968.
[26] E. Buncell, A. R. Norris and K. E. Russell, "The interaction of aromatic
nitro compounds with bases," Q. Rev. Chem. Soc., vol. 22, pp.123-125,
1968.
[27] M. J. Strauss, "Anionic sigma complexes," Chem. Rev., vol. 70, pp.
667-712, 1970.
[28] C. Hartmann, J. Smeyers-Verbeke, W. Pinninckx, Y.V. Heyden, P.
Vankeerberghen and D. L. Massart, "Reappraisal of hypothesis testing
for method validation: detection systematic error by comparing the
means of two methods or of two laboratories," Anal. Chem., vol. 67,
pp.4491-4499, 1995.
[29] Canada Health Protection Branch, "Drugs Directorate Guidelines,
Acceptable methods", Ministry of National Health and Welfare, Draft,
Ottawa, Canada , 1992.
[1] D. N. Franz, "Cardiovascular Drugs (Ed: A. R. Gennaro)," in
Remington: The Science and Practice of Pharmacy, 19th ed., Vol. II,
Mack Publishing Company, Pennsylvania, 1995, p. 951.
[2] T.G. Warner and M. C. Perry, "Ramipril: a review of its use in the
prevention of cardiovascular outcomes," Drugs, vol. 62, pp.1381-1405,
2002.
[3] Royal Pharmaceutical Society, "British Pharmacopoeia," vol. II, H. M.
Stationery Office, Royal Pharmaceutical Society, London, UK, 2000,
pp.1331-1333.
[4] Z. Zhimeng, V. Andre and N. Len, "Liquid chromatography-mass
spectrometry method for determination of ramipril and its active
metabolite ramiprilat in human plasma," J. Chromatography B., vol.
779, pp. 297-306, 2002.
[5] B. Francesco, M. Patrizia and Q. Fabiasa, "Analysis of ACE inhibtor
drugs by high performance liquid chromatography," Il Farmaco, vol. 49,
pp. 457-460, 1994.
[6] U. J. Dhorda and N. B. Shetkar, "RP-HPLC determination of ramipril
and amlodipine in tablets," Indian Drugs, vol. 36, pp. 638-641, 1999.
[7] S. S. Zarapakar and S. H. Rane, "RP-HPLC determination of ramipril
and hydrochlorothiazide in tablets," Indian Drugs, vol. 37, pp. 589-593,
2000.
[8] J. N. Harlikar and A. M. Amlani, "Simultaneous determination of
perindopril, indapamide, ramipril, trandapril in pharmaceutical
formulations using RP- HPLC," Res. J. Chem. Environ., vol. 7, pp. 59-
62, 2003.
[9] S. Hillaer, K. De Grauwe and W. Van den Bossche, "Simultaneous
determination of hydrochlorothiazide and several inhibitors of
angiotensin-converting enzyme by capillary electrophoresis,"
J.Chromatogr. A, vol. 924, pp. 439- 449, 2001.
[10] H. E. Abdellatef, M. M. Ayad and E. A. Taha, "Spectrophotometric and
atomic absorption spectrophotometric determination of ramipril and
perindopril through ternary complex formation with eosin and Cu (II),"
J. Pharm. Biomed. Anal., Vol. 18, pp. 1021-1027, 1999.
[11] M. M. Ayad, A. A. Shalaby, H. E. Abdellatef and M. M. Hosny,
"Spectrophotometric and AAS determination of ramipril and enalapril
through ternary complex formation," J. Pharm. Biomed. Anal., vol. 28,
pp. 311-321, 2002.
[12] J. A. Prieto, R. M. Jimenez and R. M. Alonso, "Square wave
voltammetric determination of angiotensin- converting enzyme
inhibitors cilazapril, quinapril and ramipril in pharmaceutical
formulation," Il Farmaco, vol. 58, pp. 343-350, 2003.
[13] H. Y. Aboul-Enein, R. I. Stefen and J. F. Van Staden, "Analysis of
several angiotensin-converting enzyme inhibitors using potentiometric,
enantioselective membrane electrodes," Anal. Lett., vol. 32, pp. 623-632,
1999.
[14] H. G. Eckert, G. Muenscher, R. Oekonomopulos, H. Strecker, H. Urbach
and H. A. Wissmann, "Radioimmunoassay for the II angiotensinconverting
enzyme inhibitor ramipril and its active metabolite,"
Arzneim.-Forsch, vol. 35, pp.1251-1256, 1985.
[15] H. H. Abdine, F. A. El-Yazbi, R. A. Shaalan and S. M.Blaih, "Direct
differential solubility and compensatory- derivative spectrophotometric
methods for resolving and subsequently determining binary mixtures of
some anti hypertensive drugs," S. T. P. Pharm Sci., vol. 9, pp.587-591,
1999.
[16] H. Salem, "Derivative spectrophotometric determination of two
component mixtures," Chin. Pharm. J., vol. 51, pp. 123-142, 1999.
[17] N. Erk, "Ratio-spectra-zero-crossing derivative spectrophotometric
determination of certain drugs in two component mixtures," Anal. Lett.,
vol. 32, pp. 1371-1388, 1999.
[18] S.M. Blaih, H. H. Abdine, F. A. El-Yazbi and R. A. Shaalan,
"Spectrophotometric determination of enalapril maleate and ramipril in
dosage forms," Spectrosc. Lett., vol. 33, pp. 91-102, 2000.
[19] F. M. Salama, O. I. A. El-Sattar, N. M. El-Aba Sawy and M.M. Fuad,
"Spectrophotometric determination of some ACE inhibitors through
charge transfer complexes," Al Azhar J. Pharm. Sci., vol. 27, pp. 121-
132, 2001.
[20] A. A. Al-Majed, F. Belal and A. A. Al-Warthan, "Spectrophotometric
determination of ramipril (a novel ACE inhibitor) in dosage forms,"
Spectrosc. Lett., vol. 34, pp. 211-220, 2001.
[21] A. A. Al-Majed and J. Al-Zehouri, "Use of 7- fluoro-4-nitrobenzo-2-
oxo-1,3-diazole for the determination of ramipril in tablet and spiked
human plasma," Il Farmaco, vol. 56, pp. 291-296, 2001.
[22] N. Rahman, Y. Ahmad and S. N. H. Azmi, "Kinetic spectrophotometric
method for the determination of ramipril in pharmaceutical
formulations," A. A. P. S. PharmSciTech., vol.6, pp. 543-551, 2005.
[23] J. Ermer, "Validation in pharmaceutical analysis. Part I: An integrated
approach.," J. Pharm. Biomed. Anal., vol. 24, pp.755-767, 2001.
[24] H. E. Bent and C. L. French, "The structure of ferric thiocyanate and its
dissociation in aqueous solution," J. Am. Chem. Soc., vol. 63, pp. 568-
572, 1941.
[25] E. Buncell, A. R. Norris and K. E. Russell, "The interaction of aromatic
nitro compounds with bases," Q. Rev. Chem. Soc., vol. 22, pp.123-125,
1968.
[26] E. Buncell, A. R. Norris and K. E. Russell, "The interaction of aromatic
nitro compounds with bases," Q. Rev. Chem. Soc., vol. 22, pp.123-125,
1968.
[27] M. J. Strauss, "Anionic sigma complexes," Chem. Rev., vol. 70, pp.
667-712, 1970.
[28] C. Hartmann, J. Smeyers-Verbeke, W. Pinninckx, Y.V. Heyden, P.
Vankeerberghen and D. L. Massart, "Reappraisal of hypothesis testing
for method validation: detection systematic error by comparing the
means of two methods or of two laboratories," Anal. Chem., vol. 67,
pp.4491-4499, 1995.
[29] Canada Health Protection Branch, "Drugs Directorate Guidelines,
Acceptable methods", Ministry of National Health and Welfare, Draft,
Ottawa, Canada , 1992.
@article{"International Journal of Chemical, Materials and Biomolecular Sciences:49989", author = "Nafisur Rahman and Habibur Rahman and Syed Najmul Hejaz Azmi", title = "Kinetic Spectrophotometric Determination of Ramipril in Commercial Dosage Forms", abstract = "This paper presents a simple and sensitive kinetic
spectrophotometric method for the determination of ramipril in
commercial dosage forms. The method is based on the reaction of the
drug with 1-chloro-2,4-dinitrobenzene (CDNB) in dimethylsulfoxide
(DMSO) at 100 ± 1ºC. The reaction is followed
spectrophotometrically by measuring the rate of change of the
absorbance at 420 nm. Fixed-time (ΔA) and equilibrium methods are
adopted for constructing the calibration curves. Both the calibration
curves were found to be linear over the concentration ranges 20 - 220
μg/ml. The regression analysis of calibration data yielded the linear
equations: Δ A = 6.30 × 10-4 + 1.54 × 10-3 C and A = 3.62 × 10-4 +
6.35 × 10-3 C for fixed time (Δ A) and equilibrium methods,
respectively. The limits of detection (LOD) for fixed time and
equilibrium methods are 1.47 and 1.05 μg/ml, respectively. The
method has been successfully applied to the determination of ramipril
in commercial dosage forms. Statistical comparison of the results
shows that there is no significant difference between the proposed
methods and Abdellatef-s spectrophotometric method.", keywords = "Equilibrium method, Fixed-time (ΔA) method,Ramipril, Spectrophotometry.", volume = "2", number = "1", pages = "1-7", }
