Optimized and Validated Spectrophotometric Method for the Determination of Ampicillin in Pharmaceutical Formulations
Determination of Ampicillin in Pharmaceutical Formulations
A simple and accurate spectrophotometric method have been proposed for the determination of ampicillin in pharmaceutical formulations. The method is based on the reaction of the carboxylic acid group of ampicillin with a mixture of potassium iodate (KIO3) and iodide (KI) to form a yellow-colored product in an aqueous medium at room temperature. The reaction is followed spectrophotometrically by measuring the absorbance at 352 nm (λmax). Beer’s law is obeyed in the concentration range of 0.25–2.5 µg/ml. The method is validated according to international conference on harmonization (ICH) guidelines in terms of specificity, linearity, linearity range, accuracy, precision, the limit of detection, the limit of quantitation, robustness, and ruggedness. The percent recoveries, relative standard deviation (RSD), and standard analytical error (SAE) for the method were also determined. The application of the proposed method to commercial dosage forms is presented.
. Ahmed MS, Mohammed RH, Fadhil MA. RP-HPLC method validation for the determination of ampicillin in Iraqi healthy volunteers serum. International Journal of Research in Pharmacy and Chemistry. 7(4): 360–366 (2017).
. Barot TG, Patidar K, Kshartri N, Vyas N. Development and validation of LC Method for the determination of ampicillin and dicloxacillin in pharmaceutical formulation using an experimental design. E-Journal of Chemistry. 6(4): 955–964 (2009).
. Simon B, Hancu G, Gyeresi A. Application of capillary electrophoresis to the simultaneous determination and stability study of four extensively used penicillin derivatives. Brazilian Journal of Pharmaceutical Sciences. 50(3): 521–527 (2014).
. Long C, Deng B, Sun S, Meng S. Simultaneous determination of chlortetracycline, ampicillin and sarafloxacin in milk using capillary electrophoresis with electrochemiluminescence detection. Food Additives and Contaminants–Part A Chemistry, Analysis, Control, Exposure and Risk Assessment. 34(1): 24–31 (2017).
. Totoli EG, Salgado HRN. Development and validation of the quantitative analysis of ampicillin sodium in powder for injection by fourier-transform infrared spectroscopy (FT-IR). Physical Chemistry. 2(6): 103–108 (2012).
. Chen L, Wang B, Diao Z, Zhao M, Xie K, Zhang P, Wang X, Zhang T, Wang J. Development and validation of an HPLC-ESI/MS/MS method for the determination of amoxicillin, its major metabolites, and ampicillin residues in chicken tissues. Molecules. 24(14): 2652 (2019).
. Parker SL, Adnan S, Meija JLO, Paterson DL, Lipman J, Roberts JA, Wallis SC. An UHPLC–MS/MS method for the simultaneous determination of ampicillin and sulbactam in human plasma and urine. Bioanalysis. 7(18): 2311–2319 (2015).
. Ezeanokete CC, Ngwoke KG, Okoye FBC, Osadebe PO. Spectrophotometric determination of ampicillin and cloxacillin in pure and fixed dosage forms through charge transfer complexation. European Chemical Bulletin. 2(12): 1009–1012 (2013).
. Misic IR, Miletic G, Mitic S, Mitic M, Marinkovic EP. A simple method for the ampicillin determination in pharmaceuticals and human urine. Chemical and Pharmaceutical Bulletin. 61(9), 913–919 (2013).
. Feigl F. Spot tests in organic analysis. Chapter 3: Preliminary (Exploratory tests), 6th edition, Elsevier publishing company, Amsterdam, 117–118 (1960).
. United States Food and Drug Administration. Guideline for industry: text on validation of analytical procedures: ICH Q2A. Rockville, MD: Mar 1995.
. United States Food and Drug Administration. Guidance for industry: Q2B validation of analytical procedures: methodology. Rockville, MD: Nov 1996.
. International conference on the harmonization of the technical requirements for registration of pharmaceuticals for human use, ICH harmonised tripartite guideline Q2(R1), Validation of analytical procedures: text and methodology, ICH Steering Committee, November 6, 1996.
This work is licensed under a Creative Commons Attribution 4.0 International License.