Analytical quality by design‐based stability‐indicating high performance liquid chromatography method for the estimation of evogliptin tartrate in bulk and tablet dosage form

Article

作者: Dhaneshwar, Suneela ; Kawathekar, Neha ; Srivastava, Shruti

AbstractThe present study utilized Analytical Quality by Design (AQbD) approach to develop a stability‐indicating high‐performance liquid chromatography (HPLC) method for estimating evogliptin tartrate using design expert software. The key parameters were methodically optimized, contours were plotted, and stability was evaluated using various forced degradation conditions. Using an Agilent HPLC system with a photo diode array (PDA) detector along with Fortis C18 column (250 × 4.6 mm, 5 μm) effectively separated the drug from its degradants. The mobile phase used was methanol: water (pH adjusted to 3.0, 76:24; v/v) at 0.8 mL/min flow rate. Evogliptin was eluted at 2.98 min, at a detection wavelength of 267 nm. The proposed method was found to be specific, precise, linear and robust. The drug was sensitive to acidic, basic, oxidative, thermal, and photodegradation resolving six degradation products. Thus, the developed AQbD‐based stability‐indicating HPLC method is applicable in analyzing evogliptin in bulk, tablet dosage form and stability samples.

2023-11-02·Journal of AOAC International

Stability-Indicating Densitometric Analysis of Evogliptin Tartrate in Bulk and Tablet Dosage Form

Article

作者: Dhaneshwar, Suneela ; Kawathekar, Neha ; Srivastava, Shruti

AbstractBackgroundEvogliptin tartrate is a novel dipeptidyl peptidase (DPP-4) inhibitor very recently introduced into the market as an oral hypoglycemic drug.ObjectiveThe literature review has revealed no reports of stability-indicating analytical methods so far for evogliptin tartrate. Thus, the goal of this study was to develop and validate a stability-indicating high-performance thin-layer chromatography (HPTLC) method for evogliptin tartrate in bulk and tablet dosage form.MethodFor the study, precoated plates of silica gel 60F254 were used as stationary phase and acetonitrile–water–formic acid (30:8:2, v/v/v) was used as a developing system. The densitometric scanning was performed at 270 nm, and the method was validated as per International Council for Harmonisation (ICH) guidelines for accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). Evogliptin was subjected to forced degradation studies and was exposed to various stress conditions such as acid/base hydrolysis, oxidation, thermal stress, and UV light.ResultsThe developed method furnished compact spots of evogliptin (Rf 0.62 ± 0.05) and was linear in the concentration range of 1–5 µg/spot. The lowest detection and quantitation values were found to be 0.331 and 1.003 µg/spot, respectively, and % recovery was found to be 101.09. The low RSD values (below 2%) for intra-day (% RSD 1.86) and inter-day (% RSD 1.43) precision studies demonstrated the preciseness of the developed method.ConclusionsAll the validation parameters were found to be within the acceptable range prescribed by ICH guidelines, indicating that the developed method was accurate, precise, selective, and reproducible. A total of five degradation products were resolved under various stress conditions.HighlightsThe proposed method has a promising application commercially for identification, routine quantitative determination, and monitoring of stability of the evogliptin tartrate in bulk and tablet dosage forms to guarantee its safety, efficacy, and quality. Moreover, the developed method will also help in formulation development and in determining the appropriate storage conditions.

2022-07-01·International Journal of Pharmaceutics

Active coating of immediate-release evogliptin tartrate to prepare fixed dose combination tablet with sustained-release metformin HCl

Article

作者: Park, Heejun ; Kim, Min-Soo ; Seo, Jeong-Woong ; Woo Jang, Sun ; Ha, Eun-Sol ; Han Won, Dong

This study was aimed to develop a fixed dose combination (FDC) tablet containing a low dose of evogliptin tartrate (6.87 mg) for immediate release combined with a high dose (1000 mg) of sustained-release (SR) metformin HCl appropriate for once daily dosing the treatment of type 2 diabetes. To prepare the FDC tablets, an active coating was used in this study, whereby evogliptin tartrate film was layered on a matrix core tablet containing metformin HCl. To overcome the problem caused by a low-dose drug in combination with a relatively large matrix tablet containing high-dose drug, it was also aimed to confirm the formulation and coating operation for satisfactory content uniformity, and to describe the chemical stability during storage of the amorphous active coating layer formulation in relation to molecular mobility. Furthermore, the in vitro release and in vivo pharmacokinetic profiles of metformin HCl and evogliptin tartrate in the FDC active coating tablet were compared to those of the commercially marketed reference drugs, Diabex XR® (Daewoong, Seoul, Korea) containing metformin HCl and Suganon® (Donga ST, Seoul, Korea) containing evogliptin tartrate. In conclusion, the newly developed FDC active coating tablet in this study was confirmed to be bioequivalent to the reference marketed products in beagle dogs, with satisfactory content uniformity and stability.

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