Development and Validation of an Ion-Exclusion Chromatographic Method for the Quantitation of Organic Acids in Complex Pharmaceutical Products

Abstract

Effective quantitation of organic acids (acetic, malic, and lactic acids) present in total parenteral nutrition (TPN) pharmaceutical products for final product release purposes requires accuracy, precision, and specificity but less than optimal sensitivity. A chromatographic method relying on ion-exclusion separation and low-wavelength ultraviolet detection has been developed and validated to quantitate these organic acids in matrices containing 10-fold or greater excesses of other constituents (sugars, amino acids, and other inorganic salts) with no sample preparation other than dilution. Mobile phases at slightly different pH values effectively eliminates matrix-related interferences that were observed during the analysis of several products. The validation procedure used is discussed in terms of its strategy and results. Ultimately, the assay is found to be appropriate for the release testing of several compositionally diverse TPN products.

Residue of 14C - Paclobutrazol in mango

“…In recovery, the values found are in the range of 70 to 120% for all products screened [6]. For quantification of the PBZ samples of pulp was used external standard method [8,9,10], using standard curve obtained under the same conditions of the sample. The calibration curve was established correlating standard versus peak area, in concentrations 0.75, 1.0, 1.5, 2.0, 3.0 µg L -1 ( Figure 2).…”

Validação de metodologia analítica para determinação de mercúrio total em amostras de urina por espectrometria de absorção atômica com geração de vapor frio (CV-AAS): estudo de caso

“…Um coeficiente de correlação maior que 0,999 é considerado como evidência de um ajuste ideal dos dados para a linha de regressão. [23][24][25] A ANVISA 14 recomenda um coeficiente de correlação maior ou igual a 0,99 e o INMETRO 16 …”

Evaluation of an Ion Exclusion/Direct Conductivity Method for Quantitating Acetic and Lactic Acids in Pharma-Ceutical LVP Base Formulations

“…Such methods include ion exchange (3)(4)(5)13) and ion exclusion (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17) separations. Such methods include ion exchange (3)(4)(5)13) and ion exclusion (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17) separations.…”