Experimental design methodology for optimization and robustness determination in ion pair RP-HPLC method development: Application for the simultaneous determination of metformin hydrochloride, alogliptin benzoate and repaglinide in tablets

Mahrouse, Marianne Alphonse; Lamie, Nesrine T.

doi:10.1016/j.microc.2019.03.038

Cited by 59 publications

(26 citation statements)

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“…A series of catalytic reactions with different bases, namely Et 3 N, DIPEA and DBU (organic soluble bases), as well as some inorganic bases, viz. K 2 CO 3 and Cs 2 CO 3 were carried out (entries [19][20][21][22]. In spite of the wide range of bases analyzed, Et 3 N provided the optimum result in terms of yield.…”

Section: Paper Syn Thesismentioning

confidence: 99%

“…A testament to the growing importance of aminocarbonylation 14 can be visualized in the form of the several well-known amide-cored compounds that have been identified in several commercially important molecules, natural products, and biologically active motifs in a variety of drug molecules (Figure 1). [15][16][17][18][19][20] Amongst the molecules of synthetic and biological relevance that have been highlighted above, echiguanine 16 A and sangivamycin 15 are particularly important due to the presence of a privileged nucleoside scaffold. In past decades, significant progress has been made on nucleoside chemistry, 21 ranging from their synthesis, modification and photophysical examination, leading to their potential exploration in the field of medicines.…”

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confidence: 99%

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Pd/PTABS: An Efficient Catalytic System for the Aminocarbonylation of a Sugar-Protected Nucleoside

et al. 2019

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A highly efficient and mild protocol for the aminocarbonylation of a nucleoside is developed by employing palladium/(1,3,5-triaza-7-phosphaadamantan-1-ium-1-yl)butane-1-sulfonate (Pd/PTABS) as the catalytic system. The developed aminocarbonylation methodology employs CO gas at a relatively low temperature of 60 °C and is suitable for a wide range of amines, including (heteroaryl)benzylic, aliphatic acyclic, alicyclic and secondary amines. This protocol is also utilized for the synthesis of a sangivamycin precursor by carrying out the Pd-catalyzed amination and aminocarbonylation simultaneously. The utility of this protocol is further demonstrated by the synthesis of the drugs moclobemide and nikethamide.

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Section: Paper Syn Thesismentioning

confidence: 99%

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confidence: 99%

Pd/PTABS: An Efficient Catalytic System for the Aminocarbonylation of a Sugar-Protected Nucleoside

et al. 2019

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“…The use of DoE in the development and optimization of chromatographic conditions is not exclusive for forced degradation studies; instead, its application has spread to several fields that use chromatography as a tool [86,87,88]. Krishna et al [89] performed forced degradation studies of eberconazole nitrate (EBZ) submitting it to hydrolytic (acid, basic, and neutral), thermal, oxidative, and photolytic degradation.…”

Section: Applications Of Chemometric Tools In Forced Degradation Smentioning

confidence: 99%

Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs

Alvarenga

Carneiro

2019

Molecules

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Chemometrics is the chemistry field responsible for planning and extracting the maximum of information of experiments from chemical data using mathematical tools (linear algebra, statistics, and so on). Active pharmaceutical ingredients (APIs) can form impurities when exposed to excipients or environmental variables such as light, high temperatures, acidic or basic conditions, humidity, and oxidative environment. By considering that these impurities can affect the safety and efficacy of the drug product, it is necessary to know how these impurities are yielded and to establish the pathway of their formation. In this context, forced degradation studies of pharmaceutical drugs have been used for the characterization of physicochemical stability of APIs. These studies are also essential in the validation of analytical methodologies, in order to prove the selectivity of methods for the API and its impurities and to create strategies to avoid the formation of degradation products. This review aims to demonstrate how forced degradation studies have been actually performed and the applications of chemometric tools in related studies. Some papers are going to be discussed to exemplify the chemometric applications in forced degradation studies.

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“…The binary mixture of AGT and MET have been analyzed simultaneously by different chromatographic methods [24–34], and UV‐spectrophotometric methods [35–37] in pure form and pharmaceutical formulation.…”

Section: Introductionmentioning

confidence: 99%

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride, and metformin impurity in bulk and pharmaceutical dosage form

Magdy

Ali

Taha

et al. 2021

J of Separation Science

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Two simple, sensitive, and reproducible methods were developed for the determination of alogliptin and metformin hydrochloride in presence of metformin impurity “melamin” in pure form and in pharmaceutical formulation. Method (A) was a thin layer chromatographic method in which separation was achieved using ethyl acetate–methanol–formic acid (6:3.8:0.2, by volume) as a developing system followed by densitometric scanning at 230 nm. Method (B) was a high‐performance liquid chromatography method; separation was achieved on C18 column, the mobile phase consisted of a mixture of sodium lauryl sulfate buffer 0.1% w/v, pH 3: methanol in the ratio 70:30, v/v and measurement was done at 220 nm. System suitability testing parameters were calculated to ascertain the quality performance of the developed chromatographic methods. The proposed methods have been validated regarding accuracy, precision, and selectivity, moreover they have been successfully applied to Westirizide tablets containing both alogliptin and metformin hydrochloride, results indicate that there was no interference from additives. No significance difference was found when these methods were compared to the reported one.

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Experimental design methodology for optimization and robustness determination in ion pair RP-HPLC method development: Application for the simultaneous determination of metformin hydrochloride, alogliptin benzoate and repaglinide in tablets

Cited by 59 publications

References 20 publications

Pd/PTABS: An Efficient Catalytic System for the Aminocarbonylation of a Sugar-Protected Nucleoside

Pd/PTABS: An Efficient Catalytic System for the Aminocarbonylation of a Sugar-Protected Nucleoside

Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride, and metformin impurity in bulk and pharmaceutical dosage form

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