Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method


The stabilities of two kinds of solutions (30 mg/mL) of Ampicillin sodium in 0.9% NaCl in water (NS, normal saline) and in sterile water (SW) in the intravenous elastomeric infusion device (Accufuser®) were evaluated based on recommended solutions and storage periods. The injectable NS- and SW-Ampicillin solutions in the Accufuser® device were stored and evaluated at controlled temperature (room temperature, 25℃ ± 2℃ and cold temperature, 4℃ ± 2℃) during 7 days. Effects of the periods of storage (from 0 to 7 days) and the temperatures of storage (RT and CT) on the physico-chemical appearances and concentrations of active compounds were determined. The visual clarity, pH, and concentrations of Ampicillin were determined by stability-indicating high-performance liquid chromatography (HPLC)-ultraviolet (UV) detection. The results showed that the amount of Ampicillin in studied solutions gradually decreased with time. The Ampicillin in NS, which was stored in CT, was relatively stable, retaining 94% of its original amount up to 7 days. The solution that showed least stability was Ampicillin in SW, which was stored in RT, retaining 80% of its original amount. Generally, solutions that were stored in CT were more stable than the solutions that were stored in RT. No significant changes in physical appearance or color of the solutions were observed during the study. Particles were not detected in any solution samples. In summary, two kinds of solutions of Ampicillin sodium, in NS and SW, showed different chemical stabilities with time in intravenous infusion device without any significant physical changes and retained about 94% vs 89% and 83% vs 80% of initial concentrations after 7 days in CT and RT, respectively. We suggest that 30 mg/mL of Ampicillin sodium in NS solution in an Accufuser® infusion device which is stored in CT can be applicable for 7 days in clinical situations.

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M. Kang and J. Kang, "Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method," Pharmacology & Pharmacy, Vol. 3 No. 4, 2012, pp. 462-467. doi: 10.4236/pp.2012.34063.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] D.M. Roberts, G. Fernando, R.F. Singer, K.J. Kennedy, M. Lawrence and G. Talaulikar, “Antibiotic stability in commercial peritoneal dialysis solutions: influence of formulation, storage and duration,” Nephrology, Dialysis, Transplantation, Vol. 26, 2011, pp. 3344–3349. doi:10.1093/ndt/gfr005.
[2] G.Y. Lee, M.J. Kim, M. Kang, Y.S. Park, S.H. Kim, S.H. Kim and J.S. Kang, “Stability of commonly used antibiotics solutions in the Accufuser? elastomeric infusion device under recommended storage and used conditions,” The Open Nutraceutical Journal, Vol. 4, 2011, pp. 125-129. doi:10.2174/1876396001104010125.
[3] M.J. Kim, G.Y. Lee, Y.S. Park, S.H. Kim, M. Kang, M.J. Kim and J.S. Kang, “Intravenous suitability studies of commonly used oxacillin sodium solutions in the Accufuser? infusion device,” Pharmacology & Pharmacy, Vol. 2, 2011, pp. 189-193. doi:10.4236/pp.2011.23027.
[4] M.L. Stiles and L.V. Allen Jr, “Stability of nafcillin sodium, oxacillin sodium, penicillin G potassium, penicillin G sodium, and tobramycin sulfate in polyvinyl chloride drug reservoirs,” American Journal of Health-System Pharmacy, Vol. 54, 1997, pp. 1068-1070.
[5] K.A. O’Bey, L.K. Jim, J.P. Gee and R.M. Johnson, “Temperature dependence of the stability of tobramycin mixed with penicillin in human serum,” American Journal of Hospital Pharmacy, Vol. 39, 1982, pp. 1005-1008.
[6] Q.A. Xu, L.A. Trissel, C.A. Saenz, D.S. Ingram and K.Y. Williams, “Stability of three cephalosporin antibiotics in AutoDose Infusion System bags,” Journal of the American Pharmacists Association (Wash), Vol. 42, 2002, pp. 428-431. doi:10.1331/108658002763316851.
[7] L.A. Trissel and Q.A. Xu, “Stability of cefepime hydrochloride in AutoDose Infusion System bags,” The Annals of Pharmacotherapy, Vol. 37, 2003, pp. 804-807. doi:10.1345/aph.1C313
[8] J.H. Fischer, M.J. Cwik, M.S. Luer, C.B. Sibley and K.L. Deyo, “Stability of fosphenytoin sodium with intravenous solutions in glass bottles, polyvinyl chloride bags, and polyethylene syringes,” The Annals of Pharmacotherapy, Vol. 31, 1997, pp. 553-559.
[9] Y. Zhang and L.A. Trissel, “Physical and chemical stability of pemetrexed solutions in plastic syringes,” The Ann of Pharma-cotherapy, Vol. 39, 2005, pp. 2026-2028. doi:10.1345/aph.1G161
[10] S.A. Farag, “Simultaneous liquid chromatographic analysis of the beta-lactam antibiotics cefazolin, cefadroxil, cephalexin, ampicillin, and cepharadine in solution,” J AOAC International, Vol. 81, 1998, pp. 381-385.
[11] A. Wildfeuer and K. Rader, “Stability of beta-lactamase inhibitors and beta-lactam antibiotics in parenteral dosage forms and in body fluids and tissue homogenates: a comparative study of sulbactam, clavulanic acid, Ampicillin and amoxicillin,” International Journal of Antimicrobial Agents, Vol. 6, 1996, pp. S31-34. doi:10.1016/S0924-8579(96)80005-7.
[12] V. Kumar, H. Bhutani and S. Singh, “ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of Ampicillin and Cloxacillin in combination drug products,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 43, 2007, pp. 769-773. doi:10.1016/j.jpba.2006.07.051.
[13] M.J. Akhtar, S. Khan and M.A. Khan, “Determination of Ampicillin in human plasma by high-performance liquid chromatography using ultraviolet detection,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 11, 1993, pp. 375-378. doi:10.1016/0731-7085(93)80031-U .
[14] J. Haginaka, J. Wakai, H. Yasuda, T. Uno, K. Takahashi and T. Katagi, “High-performance liquid chromatographic determination of Ampicillin and its metabolites in rat plasma, bile and urine by post-column degradation with sodium hypochloride,” Journal of Chromatography, Vol. 400, 1987, pp. 101-111. doi:10.1016/S0021-9673(01)81603-4.
[15] E.S. Kastango and B.D. Bradshw, “USP chapter 797: establishing a practice standard for compounding sterile preparation in pharmacy,” American Journal of Health-System Pharmacy, Vol. 61, 2004, pp. 1928-1938.
[16] L.A. Trissel, “The new national standard for sterile preparation,” Hospital Pharmacy, Vol. 39, 2004, pp. 900-904.
[17] S.E. Walker, Y. Hanabusa, G. Dranitsaris, W.R. Battle and J. Iazzetta, “Cost effective evaluation of a stability study,” Canadian Journal of Hospital Pharmacy, Vol. 40, 1987, pp. 113-118.
[18] S.E. Walker, J. Lazzstta, S. Law and K. Biniecki, “Stability of commonly used antibiotics solutions in an elastomeric infusion device,” Canadian Journal of Hospital Pharmacy, Vol. 63, 2010, pp. 212-224.
[19] E.A. Skryabina and T.S. Dunn, “Disposable infusion pumps,” American Journal of Health-System Pharmacy, Vol. 63, 2006, pp. 1260-1268. doi:10.2146/ajhp050408.
[20] K.J. Wiggins, J.C. Craig and D.W. Johnson, “Treatment for peritoneal dialysis-associated peritonitis,” Cochrane Database System Review, 2008, (1) CD005284. doi:10.1002/14651858.CD005284.pub2.

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