Simultaneous estimation of piperacillin and tazobactam in injection formulations

Pai, P. N. S.; Rao, Gopal Krishna; Murthy,; Prathibha, H.

doi:10.4103/0250-474x.31020

Cited by 6 publications

(5 citation statements)

References 1 publication

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“…In particular, it protects the antibiotic from degradation caused by beta-lactamase enzymes [29][30][31]. Up to date, in most cases, PIP and TAZ in formulations have been simultaneously analyzed through exploitation of time-consuming LC (liquid chromatography) protocols [32][33][34], a procedure that is required by pharmacopoeia for the identification of each API and its impurities [35]. Ultra-high-performance liquid chromatography tandem mass spec-trometry (UHPLC-MS/MS) has also been applied for the simultaneous determination of the two APIs, not in the formulation but in different biological matrices (serum, urine, renal replacement therapy effluent) in regard to therapeutic drug monitoring (TDM) after administration [36,37].…”

Section: Introductionmentioning

confidence: 99%

Analysis of IV Drugs in the Hospital Workflow by Raman Spectroscopy: The Case of Piperacillin and Tazobactam

2021

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Medical errors associated with IV preparation and administration procedures in a hospital workflow can even cost human lives due to the direct effect they have on patients. A large number of such incidents, which have been reported in bibliography up to date, indicate the urgent need for their prevention. This study aims at proposing an analytical methodology for identifying and quantifying IV drugs before their administration, which has the potential to be fully harmonized with clinical practices. More specifically, it reports on the analysis of a piperacillin (PIP) and tazobactam (TAZ) IV formulation, using Raman spectroscopy. The simultaneous analysis of the two APIs in the same formulation was performed in three stages: before reconstitution in the form of powder without removing the substance out of the commercial glass bottle (non-invasively), directly after reconstitution in the same way, and just before administration, either the liquid drug is placed in the infusion set (on-line analysis) or a minimal amount of it is transferred from the IV bag to a Raman optic cell (at-line analysis). Except for the successful identification of the APIs in all cases, their quantification was also achieved through calibration curves with correlation coefficients ranging from 0.953 to 0.999 for PIP and from 0.965 to 0.997 for TAZ. In any case, the whole procedure does not need more than 10 min to be completed. The current methodology, based on Raman spectroscopy, outweighs other spectroscopic (UV/Vis, FT-IR/ATR) or chromatographic (HPLC, UHPLC) protocols, already applied, which are invasive, costly, time-consuming, not environmentally friendly, and require specialized staff and more complex sample preparation procedures, thus exposing the staff to hazardous materials, especially in cases of cytotoxic drugs. Such an approach has the potential to bridge the gap between experimental setup and clinical implementation through exploitation of already developed handheld devices, along with the presence of digital spectral libraries.

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Section: Introductionmentioning

confidence: 99%

Analysis of IV Drugs in the Hospital Workflow by Raman Spectroscopy: The Case of Piperacillin and Tazobactam

2021

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“…In particular, it protects the antibiotic from degradation caused by beta-lactamase enzymes [12,14]. Up to date, in most cases, PIP and TAZ in formulations have been simultaneously analyzed through exploitation of time-consuming LC (liquid chromatography) protocols [15][16][17], a procedure that is required by pharmacopoeia for the identification of each API and its impurities [18]. Ultra high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) has also been applied for the simultaneous determination of the two APIs, not in the formulation but in different biological matrices (serum, urine, renal replacement therapy effluent) in regards to therapeutic drug monitoring (TDM) after administration [19,20].…”

Section: Introductionmentioning

confidence: 99%

FT-IR/ATR Solid Film Formation: Qualitative and Quantitative Analysis of a Piperacillin-Tazobactam Formulation

2020

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FT-IR/ATR analytical technique is one of the most applicable techniques worldwide. It is closely associated with easy-to-use equipment, rapid analysis, and reliable results. This study reports the simultaneous qualitative and quantitative analysis of two active pharmaceutical ingredients (APIs), of a piperacillin and tazobactam formulation using a film formation method. This method requires film formation on the ATR crystal, resulting from solvent evaporation of a small amount of liquid sample. Good contact between the film and the crystal led to the identification of both APIs, although tazobactam was of low content in the formulation mixture. The quantification of the APIs in the commercial mixture was also achieved, using a single calibration line with a correlation coefficient equal to 0.999, not only after film formation but also in the initial dry formulation before reconstitution. The present spectroscopic technique combined with the proposed relatively simple sample treatment outweighs chromatographic protocols already applied, which require specialized staff and are costly, time-consuming, and not environmentally friendly. Taking all the above into consideration, it turns out that such an approach has the potential to be used for off-line quality control procedures in manufacture or, in terms of portable equipment and automated software, anywhere for on-site analysis, even in a hospital workflow.

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“…1. Until date, very few analytical methods were reported for the determination of the drug individually or in combination with other drugs using techniques such as LCMS/MS [3,4], HPLC MS/MS [5], HPLC [6][7][8][9][10][11][12], and ultraviolet (UV) [13][14][15][16]. However, no analytical method is available in literature for the determination of PIP using visible spectrophotometry.…”

Section: Introductionmentioning

confidence: 99%

Piperacillin Estimation by Ion-Associative Complex Formation

Gorumutchu

Nadh

Katari³

2019

Asian J Pharm Clin Res

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Objective: The objective of the study was to develop a simple, validated, and affordable visible spectrophotometric method for determination of piperacillin (PIP) present in bulk and powder for injection formulation. Methods: In the present method, cobalt thiocyanate (CTC) was used as a chromogenic reagent where it forms 2:1 ion pair complex at pH 2 with PIP which is having secondary and tertiary amine groups. Results: The formed bluish-green colored ion pair between PIP and CTC is quantitatively extractable into nitrobenzene with an absorption maximum of 665 nm. Regression analysis (r=0.9996) shows that the plotted calibration curve exhibits good linearity in the studied range of concentration (3–18 μg/mL). Low values of relative standard deviation (<2%) were observed indicating that the proposed method is reproducible, accurate, and precise. Conclusions: As per the existing guidelines of ICH (international council for harmonization of technical requirements for pharmaceuticals for human use), various parameters of the proposed method were tested for validation and can be used method of choice for routine analysis in industrial quality control laboratories, especially in developing countries.

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Simultaneous estimation of piperacillin and tazobactam in injection formulations

Cited by 6 publications

References 1 publication

Analysis of IV Drugs in the Hospital Workflow by Raman Spectroscopy: The Case of Piperacillin and Tazobactam

Analysis of IV Drugs in the Hospital Workflow by Raman Spectroscopy: The Case of Piperacillin and Tazobactam

FT-IR/ATR Solid Film Formation: Qualitative and Quantitative Analysis of a Piperacillin-Tazobactam Formulation

Piperacillin Estimation by Ion-Associative Complex Formation

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