Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Sultana, Sharifa; Hossain, Shahadat; Islam, Samiul; Rouf, Abu Shara Shamsur

doi:10.3329/dujps.v17i1.37128

Cited by 4 publications

(1 citation statement)

References 13 publications

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“…So, the aim of the present work is to develop an accurate, sensitive and rapid RP-UHPLC method using simple mobile phase composition for routine analysis of desvenlafaxine as well as to study its detailed stressed conditions outcomes and degradation kinetics as a part of continued research work on the development, validation and force degradation of other molecules. [14][15][16][17]…”

Section: Introductionmentioning

confidence: 99%

Stability-Indicating UHPLC Method for the Determination of Desvenlafaxine: Application to Degradation Kinetics

Akter

Alam

Rabbi

et al. 2021

Dhaka Univ. J. Pharm. Sci

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This study was aimed to investigate the degradation behavior and physicochemical stability of desvenlafaxine using reversed-phase ultra-high-performance liquid chromatography (RP-UHPLC) system. The chromatogram was developed on Eclipse XDB-C8 column (150 x 4.6 mm, 5μm). The eluents were monitored through a photo diode array plus (PDA+) detector at 210 nm using an isocratic method with a flow rate of 1.5 ml/min. Mobile phase composition was 30:70 v/v mixture of 0.1 % trifluoroacetic acid (TFA) in water and methanol. Forced degradation studies were performed on drug substance of desvenlafaxine as per International Conference on Harmonization (ICH) prescribed stressed conditions (Q1A(R2) and Q1B) using hydrolytic (acidic, basic, and neutral), oxidative and photolytic methods. The drug substance was found highly labile to acidic (0.5 N hydrochloric acid, 18.65 % degradation in 2 hours at 70°C), basic (1.0 N sodium hydroxide, 11.01 % degradation in 12 hours at 70°C) and oxidative (3 % hydrogen peroxide, 17.05 % degradation in 2 hours at 50°C) stressed conditions, but a great resistance was observed towards dry heat (maximum degradation 0.27 % in 10 days from ambient to higher temperature, 80°C), moist heat (maximum degradation 0.25 % in 2 hours at 80°C and 75 % relative humidity) as well as in photolytic degradation (maximum degradation 0.23 % in 10 days at UV light of 315 - 400 nm). A pseudo-first order kinetic was followed in acidic, basic and peroxide degradation methods which paved a way to calculate the half-life of the drug substance desvenlafaxine under ICH mentioned stressed conditions. The results were also statistically analyzed and the % RSD values were compared with recommended guidelines. Dhaka Univ. J. Pharm. Sci. 20(2): 167-176, 2021 (December)

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Section: Introductionmentioning

confidence: 99%

Stability-Indicating UHPLC Method for the Determination of Desvenlafaxine: Application to Degradation Kinetics

Akter

Alam

Rabbi

et al. 2021

Dhaka Univ. J. Pharm. Sci

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Design expert software assisted development and evaluation of empagliflozin and sitagliptin combination tablet with improved in-vivo anti-diabetic activities

Hossain¹,

Jahan²,

Rahman³

et al. 2023

Heliyon

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Analytical and Bioanalytical Methods for the Determination of Dipeptidyl Peptidase-4 Inhibitors in Various Matrices: A Comprehensive Review

Hadawale,

Sharma

2025

CDR

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Background:: DPP-4 inhibitors, or gliptins, are new oral antidiabetic drugs for type 2 diabetes. They help to regulate insulin and glucagon. These drugs have the advantage of a lower risk of hypoglycemia compared to some other diabetes medications and are typically prescribed when metformin and sulphonylureas have become less effective. Objective:: This review analyses a range of analytical and bioanalytical methods for DPP-4 inhibitors, that use spectroscopic techniques, chromatographic, and hyphenated techniques for analysis. So far, no review comprising all DPP-4 inhibitors has been presented. The primary objective of this review is to present the analysts with various analytical and bioanalytical methods for the quantification and estimation of DPP-4 inhibitors in different matrices. Methods:: To improve understanding, a review was carried out by creating a database of pre-existing research from digital sources such as ScienceDirect, and PubMed. The methodology is shown in the flowchart of the literature selection process. Conclusion:: The comprehensive assessment of methods for analysing DPP-4 inhibitors can be a valuable resource for researchers and healthcare practitioners. Hitherto, no review encompassing all DPP-4 inhibitors has been presented. Therefore, gaps in the data available on a particular subject, need to be required to collect data on a particular construct. The review suggests that chromatographic techniques were majorly used for analysis wherein solvents like acetonitrile, methanol, and buffer solutions were used as mobile phases that can deteriorate HPLC columns and equipment. So, scientists could investigate new methods for the assessment of DPP-4 inhibitors using more eco-friendly solvents.

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Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Cited by 4 publications

References 13 publications

Stability-Indicating UHPLC Method for the Determination of Desvenlafaxine: Application to Degradation Kinetics

Stability-Indicating UHPLC Method for the Determination of Desvenlafaxine: Application to Degradation Kinetics

Design expert software assisted development and evaluation of empagliflozin and sitagliptin combination tablet with improved in-vivo anti-diabetic activities

Analytical and Bioanalytical Methods for the Determination of Dipeptidyl Peptidase-4 Inhibitors in Various Matrices: A Comprehensive Review

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