Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation

Babu, D. China; Chetty, C. Madhusudhana; Mastanamma, Sk.

doi:10.13005/ojc/340543

Cited by 7 publications

(9 citation statements)

References 13 publications

(12 reference statements)

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“…Additionally, we calculated the AES scales of several HPLC methods found in the literature and compared them to the NP and RP procedures currently used for ERZ assessment (Table ). AES scales ranging from 65 to 77 were calculated using several HPLC methods found in the literature. − ,,, Based on AES scales, it was discovered that all previously published HPLC methods for ERZ determination were significantly inferior to the current RP-HPTLC approach. − ,,, According to AES scales, − ,,, the majority of documented HPLC methods for ERZ determination were judged to be better than the current NP-HPTLC approach.…”

Section: Resultsmentioning

confidence: 99%

“…43 Additionally, we calculated the ChlorTox scales for several HPLC methods found in the literature and compared them to NP and RP procedures currently used for ERZ assessment (Table 9). It was calculated that the ChlorTox scales for several literature HPLC methods ranged from 1.40 to 5.10 g. [8][9][10]13,16,17 Based on ChlorTox scales, it was discovered that all previously published HPLC methods for ERZ detection were significantly less effective than the present RP-HPTLC method. [8][9][10]13,16,17 On the basis of ChlorTox scales, the majority of documented HPLC methods for ERZ detection were discovered to be better than the current NP-HPTLC approach.…”

Section: Greenness Evaluationmentioning

confidence: 99%

“…It was calculated that the ChlorTox scales for several literature HPLC methods ranged from 1.40 to 5.10 g. [8][9][10]13,16,17 Based on ChlorTox scales, it was discovered that all previously published HPLC methods for ERZ detection were significantly less effective than the present RP-HPTLC method. [8][9][10]13,16,17 On the basis of ChlorTox scales, the majority of documented HPLC methods for ERZ detection were discovered to be better than the current NP-HPTLC approach. [8][9][10]13,16,17 The most popular quantitative approach for assessing greenness is the AGREE methodology, which considers all 12 GAC criteria.…”

Section: Greenness Evaluationmentioning

confidence: 99%

“…Pharmaceutical formulations and pure forms of ERZ can be determined using the “high-performance liquid chromatographic (HPLC)” method . A number of HPLC methods have also been used to determine ERZ in combination with either sitagliptin or metformin hydrochloride. − To ascertain ERZ in rat plasma samples, an HPLC technique incorporating fluorescence detection has also been created . ERZ has also been determined in combination with sitagliptin using LC mass spectrometry (MS)/MS (LC-MS/MS) method in fixed-dose combination products .…”

Section: Introductionmentioning

confidence: 99%

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Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

Alam,

Shakeel,

Alshehri

et al. 2024

ACS Omega

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The literature does not provide any “high-performance thin-layer chromatographic (HPTLC)” techniques for the determination of a novel antidiabetic medicine, ertugliflozin (ERZ). Additionally, there are not many environmentally friendly analytical methods for ERZ measurement in the literature. A rapid, sensitive, and eco-friendly reversed-phase-HPTLC (RP-HPTLC) method was designed and validated in an attempt to analyze ERZ in marketed pharmaceutical tablets more precisely, accurately, and sustainably over the traditional normal-phase HPTLC (NP-HPTLC) method. The stationary phases used in the NP- and RP-HPTLC procedures were silica gel 60 NP-18F254S and 60 RP-18F254S plates, respectively. For NP-HPTLC, a chloroform/methanol (85:15 v/v) mobile phase was used. However, ethanol–water (80:20 v/v) was the preferred method for RP-HPTLC. Four distinct methodologies, including the National Environmental Method Index (NEMI), Analytical Eco-Scale (AES), ChlorTox, and Analytical GREEnness (AGREE) approaches, were used to evaluate the greenness of both procedures. For both approaches, ERZ detection was carried out at 199 nm. Using the NP- and RP-HPTLC techniques, the ERZ measurement was linear in the 50–600 and 25–1200 ng/band ranges. The RP-HPTLC method was found to be more robust, accurate, precise, linear, sensitive, and eco-friendly compared to the NP-HPTLC approach. The results of four greenness tools demonstrated that the RP strategy was greener than the NP strategy and all other reported HPLC techniques. The fact that both techniques can assess ERZ when its degradation products are present implies that they both have characteristics that point to stability-indicating features. 87.41 and 99.28%, respectively, were the assay results for ERZ in commercial tablets when utilizing the NP and RP procedures. Based on several validation and greenness metrics, it was determined that the RP-HPTLC approach was better than the NP-HPTLC method. As a result, it is possible to determine ERZ in pharmaceutical products using the RP-HPTLC approach.

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Section: Resultsmentioning

confidence: 99%

Section: Greenness Evaluationmentioning

confidence: 99%

Section: Greenness Evaluationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

Alam,

Shakeel,

Alshehri

et al. 2024

ACS Omega

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show abstract

“…Scrutinizing the literature discovered few publications on the analysis of Ertugliflozin unique and combined with metformin and sitagliptin. Ertugliflozin strategy development was reported for its combination with metformin RP-HPLC 5 – 11 , with sitagliptin 12 – 18 , in combination with both metformin and sitagliptin 19 . Several bioanalytical strategies utilizing LC–MS/MS approaches have been reported to detect sitagliptin in plasma and Ertugliflozin 20 , 21 .…”

Section: Introductionmentioning

confidence: 99%

Identification, isolation, and structural characterization of novel forced degradation products of Ertugliflozin using advanced analytical techniques

Salakolusu

Katari

Sharma

et al. 2023

Sci Rep

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The research elucidates the stress degradation behavior of Ertugliflozin, which is used for the treatment of type-2 diabetics. The degradation was conducted as per ICH guidelines and Ertugliflozin is relatively stable in thermal, photolytic, neutral, and alkaline hydrolysis conditions; however, considerable degradation was detected in acid hydrolysis and oxidative hydrolysis. Degradation products were identified by ultra-high-performance liquid chromatography-mass spectrometry, isolated by semi-preparative high-performance liquid chromatography, and structural characterization using high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy. Total four degradation products were identified and isolated in acid degradation, which are degradation products 1, 2, 3, and 4. Whereas in oxidative conditions, degradation product 5 was identified. All the five degradation products formed are novel, which was not reported earlier. This is the first time documented complete structural characterization of all five degradation products by using a hyphenated analytical technique. High-resolution mass, and nuclear magnetic resonance spectroscopy were used in the present study to get concrete confirmation of degradation products structures. The current method is also used to identify degradation products with shorter runtime in the future.

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Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

Addanki

2021

Futur J Pharm Sci

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Background The present investigation was proposed to develop a simple, sensitive, rapid, accurate, precise stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin. Chromatographic separation was performed with Waters Hibar C8 [100×2.1mm, 2μ] column and mobile phase acetonitrile: water (pH 3.5) [50:50%, v/v], pumped at a flow rate 0.2ml/min. The separated analytes were detected with a UV detector at a wavelength of 218nm. Results The separation of sitagliptin and ertugliflozin was done at a retention time of 0.859min and 1.570min, respectively. The present method was validated according to the ICH guidelines Q2 R1, and stability-indicating studies were carried out as per ICH guidelines Q1A R2. Intra-day and inter-day precision were found to be within acceptable limits. The linearity of the proposed method was in the concentration range of 25–125μg/ml and 3.75–22.5μg/ml for sitagliptin and ertugliflozin, respectively. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.5μg/ml and 1.53μg/ml for sitagliptin and 0.13μg/ml and 0.38μg/ml for ertugliflozin, respectively. The recovery of the method was found in between 99.7% and 100.7%. Conclusion The proposed method was able to distinguish the analytes from by-products. Hence, the method was successfully implied for stability-indicating studies and for routine examination of sitagliptin and ertugliflozin in pharmaceutical formulation.

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Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation

Cited by 7 publications

References 13 publications

Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

Identification, isolation, and structural characterization of novel forced degradation products of Ertugliflozin using advanced analytical techniques

Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

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