Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Metformin

Vetapalem, Rajani; Yejella, Rajendra Prasad; Atmakuri, Lakshmana Rao

doi:10.4274/tjps.galenos.2018.16768

Cited by 14 publications

(4 citation statements)

References 2 publications

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“…Several analytical methods for estimating VLD alone and in combination are illustrated in the literature [29][30][31][32][33][34][35], including UV spectrophotometric, HPLC, HPTLC, and LCMS approaches. For simultaneous measurement of teneligliptin and metformin, several UV spectrophotometric [36][37][38], HPTLC [38], and HPLC [39][40][41]. approaches have been reported.…”

Section: Introductionmentioning

confidence: 99%

Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC

et al. 2022

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The aim of this study was to develop a fast RP-HPLC method for simultaneous measurement of two antidiabetic formulations (vildagliptin + remogliflozin and teneligliptin + remogliflozin) under identical experimental conditions. Using the Box–Behnken approach and response surface design, the interaction and quadratic influence of three variable parameters, acetonitrile %, pH of the mobile phase, and flow rate, on resolution between the peaks were optimized. To forecast the resolution of peaks (2.7 and 6.5) for the three anti-diabetic medications, the design space with desirability function was used to find the optimal chromatographic conditions. Isocratic elution with 58:42 acetonitrile and phosphate buffer (20 mM KH2PO4, pH adjusted to 4.9 with orthophosphoric acid) over a Zorabx C18 HPLC column with a flow rate of 1.2 mL min−1 separated all three analytes in 2.5 min. In addition, the optimized HPLC process was validated using ICH recommendations. The devised HPLC method’s precision and accuracy were proven by the low percent relative standard deviation (0.60–1.65%), good percentage recovery (98.18–101.50%), and low percentage relative errors (0.20–1.82%). The method’s robustness was also proven by slightly varying the five separate parameters. Finally, the accuracy of the proposed HPLC approach was confirmed using a standard addition method for simultaneous determination of vildagliptin + remogliflozin and teneligliptin + remogliflozin from formulations. Furthermore, the findings demonstrated that experimental design can be successfully used to optimize chromatographic conditions with fewer runs. The devised HPLC method for simultaneous quantification of two binary combinations utilizing the same chromatographic conditions is fast, accurate, precise, and easy, and it might be utilized in laboratories for routine quality control investigations on both formulations.

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Section: Introductionmentioning

confidence: 99%

Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC

et al. 2022

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“…A review of the existing literature focusing on the quantitative analysis of TGT and PGZ indicated that efforts have been directed toward devising analytical methods for these individual drugs, as well as in combination with other medications. These efforts have resulted in developing various methods including UV spectroscopy [3,[12][13][14][15], HPLC [2,3,7,[16][17][18][19][20][21][22][23], high-performance thin-layer chromatography (HPTLC) [15,[24][25][26][27][28][29], and LC-MS [23,[30][31][32][33][34][35][36]. Among the various methods that have been reported, the work by Gheewala et al in 2017 provided a comprehensive account of simultaneously determining TGT and PGZ within a synthetic mixture using both UV spectroscopy and HPLC.…”

Section: Introductionmentioning

confidence: 99%

Densitometric simultaneous assessment of teneligliptin hydrobromide and pioglitazone hydrochloride in combined tablet

Sen,

Bhimani,

Sen

et al. 2023

Separation Science Plus

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A highly effective high‐performance thin‐layer chromatographic methodology has been developed and validated for the concurrent measurement of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in tablet offering excellent sensitivity, precision, accuracy, and robustness. The methodology involved using aluminum plates layered with silica gel 60F254 were used, and the solvent system consisted of a mixture of chloroform, methanol, and ammonia (8:1:0.5 v/v/v). The analysis involved scanning of the plate at a wavelength of 229 nm and analyzing the resulting densitograms. The linear correlation was established over a range of concentrations 250–3000 ng/band for teneligliptin hydrobromide hydrate and 187.5–2250 ng/band for pioglitazone hydrochloride. The method displayed detection limits of 21.29 ng/band for teneligliptin hydrobromide hydrate and 25.97 ng/band for pioglitazone hydrochloride. The quantification limits were 64.52 ng/band for teneligliptin hydrobromide hydrate and 78.71 ng/band for pioglitazone hydrochloride. The results of precision parameters showed that the % relative standard deviation of peak area was consistently below 2%, indicating high precision. The accuracy of the method was demonstrated to be between 96% and 103%. Proposed method was found to be superior and capable of overcoming the shortcomings of previously reported methods for the assessment of both the drugs.

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“…Exploration of literature reveals numerous analytical approaches for the determination of TEN, both as an individual compound and in combination with concurrently administered medications. These methods include UV spectrophotometry [1][2][3], highperformance liquid chromatography (HPLC) [4][5][6][7][8][9], and high-performance thin-layer chromatography (HPTLC) [10][11][12]. Conversely, PIO, whether as a single drug or in combination with other coadministered drugs, has been previously evaluated through diverse methodologies, including UV spectrophotometry [13,14], HPLC [15][16][17][18][19][20][21][22][23][24][25][26] and HPTLC [27,28] .…”

Section: Introductionmentioning

confidence: 99%

Stability-Indicating TLC-Densitometric and HPLC Methods for Simultaneous Determination of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Forms with Eco-Friendly Assessment

Akabari,

Gajiwala,

Patel

et al. 2023

Preprint

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The combination of multiple drugs in pharmaceutical formulations has greatly improved the management of complex medical conditions, particularly benefiting patients with type 2 diabetes mellitus. Two powerful antidiabetic agents, teneligliptin hydrobromide hydrate (TEN) and pioglitazone hydrochloride (PIO), play key roles in regulating blood glucose levels. In this study, we introduce innovative methods for the simultaneous quantification of TEN and PIO in pharmaceutical formulations, ensuring accuracy and stability assessment. Our TLC-densitometric approach employs a mobile phase consisting of Methanol, Toluene, Ethyl Acetate, and Triethylamine (1:7:2:0.1, v/v/v/v) on TLC silica gel plates, followed by densitometric scanning at 268 nm. Meanwhile, the RP-HPLC method utilizes an isocratic elution with acetonitrile and acetate buffer (pH 2.3, 60:40 v/v) on a C18 column, delivering diode-array detection at 235 nm. Both methods offer exceptional accuracy and reliability, serving as valuable tools for pharmaceutical quality control. Furthermore, our research incorporates an environmental impact assessment to align with global sustainability goals. We consider factors such as solvent consumption, waste generation, and energy usage, using assessment tools like the eco-scale assessment, AGREE, Green Analytical Procedure Index (GAPI), and the national environmental method index (NEMI) to gauge the environmental impact of our methods. By adopting these techniques, pharmaceutical companies can enhance their drug quality control processes and fulfill their environmental responsibilities. Comprehensive statistical comparisons, including t-tests and F-tests, validate the outcomes of the TLC-densitometric and RP-HPLC methods, ensuring their effectiveness in drug formulation analysis.

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Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Metformin

Cited by 14 publications

References 2 publications

Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC

Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC

Densitometric simultaneous assessment of teneligliptin hydrobromide and pioglitazone hydrochloride in combined tablet

Stability-Indicating TLC-Densitometric and HPLC Methods for Simultaneous Determination of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Forms with Eco-Friendly Assessment

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