Validated Stability Indicating and Assay Method Development of Linagliptin in Formulation by RP-HPLC Using Quality by Design

Ganorkar, Anvesha V.; Askarkar, Sonali S.; Gupta, Krishna; Umekar, Milind J.

doi:10.17807/orbital.v12i2.1194

Cited by 3 publications

(3 citation statements)

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“…As the sponsors must submit preclinical studies, non-human pharmacology and toxicology studies, clinical pharmacology, bioavailability, and bioequivalence evaluations to regulatory authorities, it is necessary to develop and validate bioanalytical methods. The biological matrices used in the development of the bioanalytical methods include blood, serum, plasma, and urine 26 . The bioanalysis process involves several steps, from sample collection to sample analysis and data reporting, and it analyses the drugs, metabolites, and biomarkers in biological samples.…”

Section: Bioanalytical Methods Development and Validationmentioning

confidence: 99%

A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

Kemiset¹

2023

Journal of Pharmaceutical Negative Results

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The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in marketing approval. The objective of this paper is to review the method development, Impurity profile study, Degradation studies of the method for the drug production i.e Empagliflozin (EMP) and Linagliptin (LIN) from the developmental stage of the formulation to commercial batch of the product. Bioanalysis plays a vital role in drug discovery and development for the analysis of analytes (drugs, metabolites) in biological samples. To achieve a stable, reliable, and robust method one has to remove the interfaces from the sample matrix to improve bioanalytical system performance. This review provides an overview of the Impurity profile, Degradation study and various Analytical/Bio-Analytical method development of selected Anti-Diabetic drugs i.e EMP and LIN in single dosage form and their combination and a detailed investigation of different analytical techniques used for detection and quantification of these drugs on various matrices. Various techniques like spectroscopy, chromatography, electrochemical methods, and hyphenated techniques were reported to determine Anti-Diabetic drugs, either alone or in combination with other drugs, in different kinds of matrices like in bulk, existing dosage forms and also biological samples like plasma, serum, urine and myocardial tissue. Among various techniques used, HPLC, LC-MS systems are more commonly used because of their high sensitivity. This article summarizes the research works carried out since 2015 and intends to act as a handbook for future researchers.

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Section: Bioanalytical Methods Development and Validationmentioning

confidence: 99%

A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

Kemiset¹

2023

Journal of Pharmaceutical Negative Results

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“…Linagliptin decreases blood sugar levels by inhibiting DPP-4 and elevating According to a review of the literature, Linagliptin has been estimated using UV and HPLC methods. [7][8][9][10][11] However, these techniques are a little more expensive, require more sophisticated equipment, and take longer to complete. Linagliptin still requires the development of an easy, affordable, and accurate analytical approach.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC

Avinash¹,

Gandhimathi²

2023

IJPQA

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The objective of the current research was to develop and validate the reversed-phase high performance liquid chromatography (RP-HPLC) method for linagliptin from formulation and bulk material. The development was performed on C18 stainless steel column using 0.1 M TEA pH 5.5 adjusted with OPA and methanol (30:70% v/v) at 0.7 mL/min fl ow rate. Samples were analyzed by 1024 DAD detector at 238 nm. The developed method complied with the system suitability study with acceptable asymmetric factor and number of theoretical plates. The linearity was observed between 10–50 μg/mL concentrations (R2 = 0.999). The mean %recovery of 99.33 to 99.88% with %RSD between 0.13 to 0.24 was observed. The drug content was found within the acceptable limit in interday and intraday precision study. The method was fond robust and small changes in fl ow rate, mobile phase and wavelength did not hamper the accuracy and specifi city of the method and all results were found within acceptable limit. Limit of detection (LoD) and limit of quantitation (LoQ) of 0.17854 and 0.54105 μg/mL, respectively, were observed. This research confi rmed the development of simple, robust, sensitive, accurate and cost-eff ective methods that can be used to analyze Linagliptin using RP-HPLC from tablet and bulk dosage.

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“…According to the literature review it was found that, many analytical techniques have been reported for the determination of EMP and LIN, including UV spectrophotometry (Amrutiya et al, 2017;Ayoub, 2016;Cholke et al, 2019;Padmaja & Veerabhadram, 2015), voltammetry (Naccar, Saleh, Omar, Haredy, & Derayea, 2020), HPTLC (Bhole, Wankhede, & Pandey, 2017;Thakor, Amrutkar, & Chaudhari, 2019), HPLC (Abdel-Ghany, Ayad, & Tadros, 2018Al-Sabti & Harbali, 2020;Attimarad, Nagaraja, Aldhubaib, Nair, & Venugopala, 2014;Basak, Gouru, Bera, & Nagappan, 2019;Donepudi & Achanta, 2018;El-Bagary, Elkady, & Ayoub, 2013;Ganorkar, Askarkar, Gupta, & Milind, 2020;Geetha Swarupa, Lakshmana Rao, Prasad, & Suresh Babu, 2016;Gholami, Bahrami, & Faraji, 2020;Manoel et al, 2020;Naazneen & Sridevi, 2016;Padmaja & Veerabhadram, 2017;Rajbangshi, Alam, Hossain, Islam, & Rouf, 2018;Salapaka et al, 2019;Sharif et al, 2020;Supriya Reddy, Chandan, Sai Charan, & Akshay, 2020;Vemula, Dodda, Balekari, Panga, & Veeresham, 2015;Wattamwar, Mungantiwar, Halde, & Pandita, 2020;Yadav, Dornala, Swain, Prabha, & Samanthula, 2020), UPLC (Ayoub, 2015;Dubey, Singh, Tyagi, Bhardwaj, & Raghav, 2014;Jagadabi, Kumar, Pamidi, Ramaprasad, & Nagaraju, 2018;Madana Gopal & Sridhar, 2017;Nannapaneni, Jalalpure, Muppavarapu, & Sirigiri, 2016)…”

Section: Introductionmentioning

confidence: 99%

Determination of linagliptin and empagliflozin by UPLC and HPTLC techniques aided by lean six sigma approach

El-Desouky

Abdel-Raoof

Abdel‐Fattah

et al. 2021

Biomedical Chromatography

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Two chromatographic techniques were developed and validated for simultaneous determination of the newly co-formulated antidiabetic combination linagliptin and empagliflozin in their pure form and film-coated tables. The first technique was UPLC; the separation and resolution of both analytes were achieved using a Zorbax eclipse plus C 18 column applying an isocratic elution based on phosphate buffer pH 4-acetonitrile (65:35, v/v) as a running mobile phase at flow rate 1.5 ml/min and the effluent was monitored at 220 nm. Augmentation of Lean Six Sigma with UPLC and

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Validated Stability Indicating and Assay Method Development of Linagliptin in Formulation by RP-HPLC Using Quality by Design

Cited by 3 publications

References 0 publications

A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC

Determination of linagliptin and empagliflozin by UPLC and HPTLC techniques aided by lean six sigma approach

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