New spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations

• Autorzy: Rahman N. , Azmi S.N.H.
• Języki publikacji: EN

Abstrakty

EN

Two simple, sensitive and economical spectrophotometric methods were developed for the determination of nifedipine in pharmaceutical formulations. Method A is based on the reaction of the nitro group of the drug with potassium hydroxide in dimethyl sulphoxide (DMSO) medium to form a coloured product, which absorbs maximally at 430 nm. Method B uses oxidation of the drug with ammonium molybdate and subsequently reduced molybdenum blue is measured at 830 nm. Beer's law is obeyed in the concentration range of 5.0-50.0 and 2.5-45.0 µg ml-1 with methods A and B, respectively. Both methods have been successfully applied for the assay of the drug in pharmaceutical formulations. No interference was observed from common pharmaceutical adjuvants. The reliability and the performance of the proposed methods are established by point and interval hypothesis tests and through recovery studies.

Słowa kluczowe

EN

validation; nifedipine; calcium channel blocker; spectrophotometry; ammonium molybdate; potassium hydroxide; pharmaceutical formulation; cardiac muscle cell

• Wydawca: -
• Czasopismo: Acta Biochimica Polonica
• Rocznik: 2005
• Tom: 52
• Numer: 4
• Opis fizyczny: p.915-922,fig.,ref.

Twórcy

autor

Rahman N.

• Aligarh Muslim University, Aligarh, India

autor

Azmi S.N.H.

Bibliografia

• Bretnall AE, Clarke GS (1995) Investigation and optimization of the use of micellar electrokinetic chromatography for the analysis six cardiovascular drugs. J Chromatogr A 700: 173–178.
• British Pharmacopoeia (1993) vol 1, p 449. Her Majesty Stationary Office, London.
• Britton HTS (1942) Solutions of known hydrogen concentration. In Hydrgen Ions, vol I, p 304. Chapman and Hall Ltd, London.
• Canadian Health Protection Branch Guideline (1992) In Acceptable methods. Ministry of National Health and Welfare, Canada Health Protection Branch, Ottawa, Canada.
• Christian GD (2004) Data Handling, In Analytical Chemistry, 6th edn, p 90. John Wiley and Sons, Inc., Singapore.
• Delgado JN, Remers WA (1991) Wilson and Gisvold’s Text Book of Organic Medicinal and Pharmaceutical Chemistry, 9 edn, p 554. JB Lippincott Company, Philadelphia.
• Dumitrescu V, David V, Pavel A (2001) Polarographic determination of nifedipine and chloramphenical. Rev Chim 52: 317–320.
• El-Walily AFM (1997) Analysis of nifedipine-acebutolol hydrochloride binary combination in tablets using Uvderivative spectroscopy, capillary gas chromatography and high performance liquid chromatography. J Pharm Biomed Anal 16: 21–30.
• Golcu AY, Serin S (1998) Spectrophotometric determination of nifedipine via charge transfer complexes. Sci Pharm 66: 341–349.
• Hartmann C, Smeyers-Verbeke J, Penninckx W, Heyden YV, Vankeerberghen P, Massart DL (1995) Reappraisal of hypothesis testing for method validation: Detection of systematic error by comparing the means of two methods or of two laboratories. Anal Chem 67: 4491–4499.
• International Conference on Harmonisation (1995) ICH Harmonised Tripartite Guideline-Text on Validation of Analytical Procedures. Fed Regist 60: 11260.
• Ermer J (2001) Validation in pharmaceutical analysis. Part I: An integrated approach. J Pharm Biomed Anal 24: 755–767.
• Karadi AB, Ravi KUM, Shobha M, Raju S (2000) A spectrophotometric determination of nifedipine. East Pharm April: 117–118.
• Kumazawa T, Sato K, Seno H, Suzuki O (1993) Positiveand negative-ion mass spectrometry and rapid extraction with sep-pak C18 cartridges for dihydropyridine calcium antagonists and their photodecomposition products. Hochudoku 11: 128–129.
• Mahadik KR, Byale GB, More HN, Kadam SS (1991) A spectrophotometric method for estimation of nifedipine and its formulations. J Inst Chem 63: 218.
• Maiti S, Patel BH, Pandya BM (1982) A simple method for analysis of nitrobenzene in aniline. Indian J Chem A 21: 279–281.
• Martindale The Extra Pharmacopoeia (2002) 33rd ed, pp 940–946, Royal Pharmaceutical Society, London.
• Miller RJ (1987) Multiple calcium channels and neuronal function. Science 235: 46–52.
• Murdoch D, Brogden RN (1993) Sustained release nifedipine formulations: an appraisal of their current uses and prospective roles in the treatment of hypertension, ischaemic heart disease and peripheral vascular disorders. Drugs 46: 961–975.
• Niopas I, Daftsios AC (2003) Determination of nifedipine in human plasma by solid phase extraction and high performance liquid chromatography: validation and application to pharmacokinetic studies. J Pharm Biomed Anal 32: 1213–1218.
• Patravale VB, Nair VB, Gore SP (2000) High-performance thin-layer chromatographic determination of nifedipine from bulk drug and from pharmaceuticals. J Pharm Biomed Anal 23: 623–627.
• Pietta PG, Rava A, Biondi P (1981) High performance liquid chromatography of nifedipine, its metabolites and photochemical degradation products. J Chromatogr 210: 516–521.
• Porter CC (1955) Color reaction for determination of some aromatic nitro compounds. Anal Chem 27: 805–807.
• Qin Y, Liu H, He X, Zhuang H (2000) Determination of nifedipine in plasma by capillary gas chromatography. Shanghai Dier Yike Daxue Xuebao 20: 512–513.
• Rahman N, Azmi SNH (1999) Method for determination of nifedipine in pure form and in pharmaceutical preparations. Acta Pharm 49: 113–118.
• Rahman N, Hoda MN (2002) Spectrophotometric method for the determination of nifedipine with 4- (methylamino)phenol and potassium dichromate. Il Farmaco 57: 435–441.
• Rahman N, Khan NA, Azmi SNH (2004) Extractive spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations using bromocresol green, bromophenol blue, bromothymol blue and eriochrome black T. Il Farmaco 59: 47–54.
• Richter P, Toral MI, Quiroz G, Jaque P (1997) Flow-through polarographic cell for flow-injection analysis. Determination of nifedipine in pharmaceutical formulations. Lab Rob Autom 9: 255–262.
• Sastry CSP, Chintalapati R, Venkateswarlu R (1997) A simple spectrophotometric method for estimation of nifedipine. J Inst Chem 69: 187.
• Stone PH, Antman EM, Muller JE, Braunwald E (1980) Calcium channel blocking agents in the treatment of cardiovascular disorders. Part II. Hemodynamic effects and clinical applications. Ann Inter Med 93: 886–904.
• The United States Pharmacopoeia (2000) 24th ed, pp 1182–1185, Rockville, MD, USA.
• Tu J, Peng J, Xin J, Liu G (1995) Determination of nifedipine in human plasma by gas chromatography-mass spectrometry, Zhonggno Yiyuan Yaoxue Zazhi 15: 197–199.
• Umapathi P (1994) Determination of atenolol, nifedipine, aspirin and dipyridamole in tablet preparations by second-order derivative spectrophotometry. Int J Pharm 108: 11–19.
• Vyas SP, Goswami SK (1993) A sensitive visible spectrophotometric method for the estimation of nifedipine. Indian Drugs 30: 342–344.
• Wang Z, Tang X, Hou J, Pan C, Wei X (1981) Quantitative determination of nifedipine and atenolol in sustainedrelease two-layer tablets by HPLC. Shenyang Yaoke Daxue Xuebao 19: 38–40.
• Yuan G, Zhu B (1996) UV spectrophotometry of nifedipine tablets. Zhongguo Yiyao Gongye Zazhi 27: 171–172.
• Zhang Y, Liu Z, Guo Y, Gu X (2001) Determination of nifedipine in human serum by micellar liquid chromatography. Zhongguo Yiyuan Yaoxue Zazhi 21: 152–153.