Stability Studies of Cefepime Hydrochloride by Stability Indicating RP-HPLC Method

DOI:

https://doi.org/10.37285/ijpsn.2013.6.3.10

Authors

  • Behin Sundara Raj
  • I S R Punitha
  • S Krishnan

Abstract

Drug stability and compatibility are critical issues controlling accurate and appropriate delivery of drug therapy to patients. Stability is very important for antibacterial agents especially those given by intravenous route as they reach systemic circulation directly, and the clinical outcome and safety are directly correlated to drug levels in blood. The physical and chemical stability of Cefepime hydrochloride, a fourth generation cephalosporin, was determined at three different temperatures (5 °C/ 60 %RH, 25 °C/60 %RH & 45 °C/75% RH) and quantified by using a stability indicating RP-HPLC method.  Decrease in drug concentration by more than 10% from initial concentration (0 time) was considered unstable (chemical instability).  Change in pH by more than 1 was considered unstable (Physical instability). The drug solutions were clear and light yellow initially with intensity increasing over time, eventually becoming dark yellow for cefepime. HPLC analysis indicated that 40 mg/ml concentration of cefepime hydrochloride maintained adequate stability for 2 hours at 45°C and up to 24 hours at 25 °C and up to 7 days at 5 °C.

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Keywords:

Cefepime, Stability studies, RP-HPLC, Physical instability, Chemical instability, Degradation

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Published

2013-11-30

How to Cite

1.
Raj BS, Punitha ISR, Krishnan S. Stability Studies of Cefepime Hydrochloride by Stability Indicating RP-HPLC Method. Scopus Indexed [Internet]. 2013 Nov. 30 [cited 2024 Nov. 19];6(3):2181-6. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/641

Issue

Vol. 6 No. 3 (2013): October-December 2013

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

References

Ahuja S (1998). Impurities Evaluation of Pharmaceuticals, Marcel Dekker, Inc, 2nd edition, New York.

Ahuja S, and Alsante K.M (2003). Handbook of Isolation and Characterisation of Impurities in Pharmaceuticals, Academic Press, 4th edition, San Diego.

AHFS Drug Information (2004), American society of Health system Pharmacists: Cefepime Hydrochloride, 2nd edition, America.

Baririan N, Chanteux H, Viaene E, Servais H, and Tulkens PM (2003). Stability and compatibility study of cefepime in comparison with ceftazidime for potential administration by continuous infusion under conditions pertinent to ambulatory treatment of cystic fibrosis patients and to administration in intensive care units, J Antimicrob Chemother, Vol.51: 651-658.

Data Sheet. RxMed: pharmaceutical Information – MAXIPIME.

Dean DA, and Carstensen JT (2000b). Drug Stability, Principles and Practices, Marcel Decer, Inc, 2nd edition,New York.

FDA, Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products, FDA, Rockville, MD, 1998a.

FDA, Guidance for Industry: Impurities in Drug Product, Draft guidance, Center for Drug Evaluation and Research (CDER), 1998b.

Grimm W, and Carstensen JT (2000a). Drug Stability, Principles and Practices, Marcel Decer, Inc, 2nd edition, New York.

International Conference on Harmonisation (ICH) (2000). Guidance for Industry, Q1A(R2): Stability Testing of New Drug Substances and Products, IFPMA, Geneva.

Sprauten PF, Beringer PM, Louie SG, Synold TW, and Gill MA (2003). Stability and antibacterial activity of cefepime during continuous infusion. AAC, 1991-1994.

Turco, SJ (1994). Sterile dosage forms, Lea & Febiger Publishing, 4th edition, Philadelphia.

USP-2004; Asian Edition, NF-22: Cefepime hydrochloride, 4th edition, New Delhi.