African Journal of
Pharmacy and Pharmacology

  • Abbreviation: Afr. J. Pharm. Pharmacol.
  • Language: English
  • ISSN: 1996-0816
  • DOI: 10.5897/AJPP
  • Start Year: 2007
  • Published Articles: 2281

Full Length Research Paper

Development and validation of simple and rapid high performance liquid chromatographic method for routine analysis of human insulin in formulations

Mohammad Javed Ansari*
  • Mohammad Javed Ansari*
  • Department of Pharmaceutics, College of Pharmacy, Salman Bin Abdulaziz University, Al-kharj, Saudi Arabia.
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Shahid Jamil
  • Shahid Jamil
  • Department of Pharmaceutics, College of Pharmacy, Salman Bin Abdulaziz University, Al-kharj, Saudi Arabia.
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Mohammad Khalid Anwer
  • Mohammad Khalid Anwer
  • Department of Pharmaceutics, College of Pharmacy, Salman Bin Abdulaziz University, Al-kharj, Saudi Arabia.
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Ramdhan Al-shdefat
  • Ramdhan Al-shdefat
  • Department of Pharmaceutics, College of Pharmacy, Salman Bin Abdulaziz University, Al-kharj, Saudi Arabia.
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Bahaeldin Elsyed Ali
  • Bahaeldin Elsyed Ali
  • Department of Pharmaceutics, College of Pharmacy, Salman Bin Abdulaziz University, Al-kharj, Saudi Arabia.
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  •  Received: 11 April 2013
  •  Accepted: 17 October 2014
  •  Published: 29 October 2014

References

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Oliva A, Farina JB, Llabres M (1996). Influence of temperature and shaking on stability of insulin preparations: Degradation kinetics. Int. J. Pharm. 143: 163-170.
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Asahara K, Yamada H, Yoshida S (1991). Stability of human insulin in solutions containing sodium bisulfate. Chem. Pharm. Bull. 39: 2662-2666.
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Moussa BA, Farouk F, Azzazy HME (2010). A Validated RP-HPLC Method for the Determination of Recombinant Human Insulin in Bulk and Pharmaceutical Dosage Form. E-J. Chem. 7(S1):S449-S457.
 
Chen XJ, Zhu JB, Wang GJ, Zhou MX, Xu YN (2002). HPLC determination of insulin and its related substances in insulin powder for inhalation. Yao Xue Xue Bao 37:131-133.
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Chien YW (1996). Human insulin: Basic sciences to therapeutic uses. Drug. Dev. Ind. Pharm. 22: 753-789.
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Farid NA, Atkins LM, Becker GW, Dinner A, Heiney RE, Miner DJ, Riggin RM. (1989). Liquid chromatographic control of the identity, purity and "potency" of biomolecules used as drugs. J. Pharm. Biomed. Anal. 7:185-188.
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International Conference on Harmonization, (ICH) (1997). Q2B, Validation of Analytical Procedures, Methodology, May 1997.
 
Rajan DS, Gowda KV, Mandal U, Ganesan M, Bose A, Sarkar AK, Pal TK (2006). Development of RP-HPLC for analysis of human insulin. Ind. J. Pharm Sci. 68: 662-665.
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The United States Pharmacopoeia/National Formulary (2007). USP 30th/ NF 25, New York, Twinbrooke Parkway. P 1375.
 
Yılmaz B, Kadıoglu Y (2010). Development and validation of HPLC method for determination of human insulin in pharmaceutical preparation. IJPSRR 2:40-43.
 
Yomota C, Yoshii Y, Takahata T, Okada S. (1996). Separation of B-3 monodesamidoinsulin from human insulin by high-performance liquid chromatography under alkaline conditions. J. Chromatogr. A. 721:89-96.
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