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.

Piperacillin Estimation by Ion-Associative Complex Formation

Received on: 10.09.2018 Revised on: 06.12.2018 Accepted on: 09.12.2018 A simple, validated and affordable visible spectrophotometric method was developed for the determination of piperacillin present in bulk and tablet formulation. The proposed method involves the development of a coloured ionassociation complex between piperacillin cation and tropaeolin-ooo anion, which can be further extracted in chloroform. In the formation of cation from piperacillin, site of protonation is oxygen of amide group. Two secondary amides of piperacillin are protonated to form a doubly charged cation. Maximum absorption was observed at 529 nm for the coloured complex. Regression analysis (r = 0.9999) shows that the plotted calibration curve exhibits good linearity in the studied range of concentration (4.0–24.0 μg mL-1). As per the existing guidelines of ICH, various parameters (interday precision, intraday precision, accuracy, ruggedness, LOD, LOQ) of the method were tested for validation. Low values of relative standard deviation (< 2 %) were observed indicating that the proposed method is reproducible, accurate and precise. The proposed method was extended to assay piperacillin powder for injection formulation.

/pdf/ion-associative-complex-formation-for-the-stimation-of-1lr1ze351i.pdf

Ion Associative Complex Formation for the Stimation of Piperacillin

/pdf/piperacillin-estimation-by-ion-associative-complex-formation-1tfcwmmmoc.pdf

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.

https://www.mdpi.com/1420-3049/25/24/6051/pdf

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

A new method for the determination and extraction of ethinyl estradiol and etonogestrel was developed for a pharmaceutical product consisting of a solid copolymer intrauterine ring for subsequent simultaneous quantification by ultraviolet-visible derivative spectrophotometry. The spectral variables were optimized for first derivative spectrophotometry with a smoothing factor of 4000 and an amplification factor of 10,000. A wavelength of 291.5 nm was selected for the determination of ethinyl estradiol by a graphical method, while for etonogestrel, zero-crossing was used at 249.5 nm. The limits of detection and quantification for ethinyl estradiol were 9.5 × 10−7 and 9.0 × 10−6 mol/L and 1.1 × 10−6 and 3.2 × 10−6 mol/L for etonogestrel, respectively. For the extraction method, the variables affecting the analytical signal were the extraction solvent, temperature, and extraction time; optimized conditions were 180 min at 76 ± 2°C in acetonitrile. The method was applied successfully for the first time to anal...

Determination of Etonogestrel and Ethinyl Estradiol from an Intrauterine Contraceptive Ring by Extraction and Derivative Spectrophotometry

In this paper, a simple and rapid method was developed for the simultaneous determination of Piperacillin (PIP) and Tazobactam (TAZ) by second-order derivative spectrophotometry. Water was selected as a solvent for extraction and determination of both analytes. Further studies of photo-stability and forced degradation for both drugs were also performed. The spectral variables were optimized, a smoothing factor of 8•10 3 and a scaling factor of 1•10 4 were selected and the analytical signals were evaluated at 296.3 nm and 233.3 nm for PIP and TAZ, respectively.The detection and quantification limits for PIP and TAZ were: 3.2•10 -7 to 9.5•10 and 2.7•10 -7 to 8.9•10 -7 mol/L, respectively. The levels of repeatability (RSD) were 1.5% and 2.4% for PIP and TAZ respectively.The method was applied to the pharmaceutical formulation TAZONAM NF® Wyeth. USA, with a nominal content of 4.0 g of PIP, 0.5 g of TAZ, 0.139 g of citric acid and 1 mg of EDTA. A study of excipients was carried out and it was found that they do not interfere with quantification. By applying this method, a content of 3.96 ± 0.04 g and 0.57 ± 0.01 g was found of PIP and TAZ, respectively.

/pdf/simultaneous-determination-of-piperacillin-and-tazobactam-in-27ndt10eoc.pdf

Simultaneous determination of piperacillin and tazobactam in the pharmaceutical formulation tazonam® by derivative spectrophotometry

This work presents a rapid and simple method for the parallel determination of Desogestrel (DSG) and 17α-Ethinylestradiol (EE2) by second order derivative spectrophotometry and its application in pharmaceutical formulations. Study of the effect of the solvents, excipients and spectral behavior is also included. Acetonitrile was selected as a solvent; subsequently the samples were evaluated by second order derivatives, using a smoothing factor of 8,000 and a scale factor of 10 4 . The EE2 determination was carried out using the graphical method at 288 nm and DSG by the zero-crossing method at 220 nm. The determination ranges were found to be between 1.5·10 -6 and 5·10 -4 mol/L and 1.7·10 -7 to 1.0·10 -3 mol/L for DSG and EE2, respectively.The homogenized tablets are divided in two fractions, the first, called sample A, was dissolved in acetonitrile, which contains the absorbents species that is polyvidone, DGS and EE2, the latter is determined directly at 288 nm. Meanwhile, in the second fraction (sample B), after extract with water the polyvidone and partially EE2, it is possible determine DGS at 220 nm. When the pharmaceutical formulation contains Vitamin E (Vit. E) is necessary to use an equations system to be evaluated in sample B.

/pdf/parallel-determination-of-desogestrel-and-17a-20575mu1l1.pdf

PARALLEL DETERMINATION OF DESOGESTREL AND 17α-ETHINYLESTRADIOL IN PHARMACEUTICAL FORMULATION BY DERIVATIVE SPECTROPHOTOMETRY

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Simultaneous determination of piperacillin and tazobactam in the pharmaceutical formulation tazonam® by derivative spectrophotometry

PARALLEL DETERMINATION OF DESOGESTREL AND 17α-ETHINYLESTRADIOL IN PHARMACEUTICAL FORMULATION BY DERIVATIVE SPECTROPHOTOMETRY