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A combination of fixed dose tablet containing 0.5 mg lobeglitazone sulfate (LBZ) and 1 mg glimepiride (GLM) has demonstrated efficacy in enhancing glycemic control in diabetes. The projected work aimed to develop and validate a high‐performance thin‐layer chromatographic (HPTLC) methodology for the precise quantification of both the drugs in tablet formulations. The HPTLC analysis utilized aluminium plates layered with silica gel 60F254, and the solvent system consisted of ethyl acetate, benzene, and hexane (4:3:1 v/v/v) followed by densitometric scanning at 238 nm. The Rf value was found to be 0.68 ± 0.001 for LBZ and 0.48 ± 0.002 for GLM. The methodology exhibited linearity in the range of 100–2000 ng/band for LBZ and 200–4000 ng/band for GLM, with correlation coefficients of 0.9988 and 0.9981, respectively. Exceptional sensitivity was observed, with detection limits of 23.86 ng/band for LBZ and 58.26 ng/band for GLM, along with quantification limits of 72.32 ng/band for LBZ and 176.55 ng/band for GLM. The method demonstrated precision (% relative standard deviation of peak area < 2) and accuracy (recovery between 97% and 102%). The suggested method is suitable for quantifying both the drugs in tablets, making it useful for routine quality control in laboratories. [ABSTRACT FROM AUTHOR]

The current study aims to develop and validate an analytical quality by design approach‐based high‐performance thin‐layer chromatographic (HPTLC) method for the analysis of Axitinib tablet samples. The chromatographic conditions in the TLC method were optimized using a three‐level full factorial design. The mobile phase composition and chamber saturation time served as the independent variables for optimization. The mobile phase used for TLC separation on pre‐coated aluminum plates with silica gel 60 F254 consisted of a mixture of ethyl acetate and isopropyl alcohol in a ratio of 9:1 (v/v). Axitinib was quantified at 330 nm using the densitometric method. Axitinib peak from tablet formulation was verified against the reference standard by comparing its single band at Rf 0.44 ± 0.02. Linearity was found to exist between 100 and 600 ng/band, with a correlation coefficient (r2) of 0.9978. The percentage recovery was obtained as 98.21%–99.05%. The system was validated by determining the parameters according to the guidelines of the International Council for Harmonization of Technical Conditions for Medical Products for Human Use. The proposed TLC method can be effectively applied to routine quality control of a pharmaceutical product. [ABSTRACT FROM AUTHOR]

Enhanced glycemic regulation in individuals with diabetes mellitus can be achieved using a fixed‐dose combination of dapagliflozin (10 mg) and vildagliptin (100 mg) in tablet. The primary objective of this research was to develop and validate a high‐performance thin layer chromatographic methodology for accurately measuring the quantities of dapagliflozin and vildagliptin in combined tablet formulation. The methodology involved using aluminum plates layered with silica gel 60F254, and the solvent system comprised of acetonitrile, benzene, and glacial acetic acid (9:1:2 v/v/v). Densitograms were scanned at a wavelength of 210 nm. The linearity of the procedure was established in the series of 200–2500 ng/band for dapagliflozin and 2000–25000 ng/band for vildagliptin, with correlation coefficients (r2) of 0.9931 and 0.9954, correspondingly. The method demonstrated good sensitivity, with detection limits of 21.07 ng/band for dapagliflozin and 154.97 ng/band for vildagliptin; quantification limits of 63.84 ng/band for dapagliflozin and 469.60 ng/band for vildagliptin. The methodology was found to be precise (% relative standard deviation of peak area <2) and accurate (recovery between 97% and 103%). Proposed method was found to be superior and capable of overcoming the shortcomings of previously reported methods for the assessment of dapagliflozin and vildagliptin in combined formulation. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

For the purpose of analyzing empagliflozin, a stability indicating high performance thin layer chromatographic method was developed. This method was optimized using design of experiment. In order to optimize the process, independent variables such as the proportion of isopropyl alcohol in the mobile phase, the duration of time that the chamber was saturated and the distance of mobile phase travelled were considered. On an aluminum plate that had previously been coated with silica gel, development was carried out with the assistance of twin trough glass chambers in ascending lines. The findings from these studies led to the selection of a mobile phase that had a composition of ammonium acetate (2 %), triethylamine and isopropyl alcohol in the ratio of 4:1:5 (V/V/V), and this mobile phase was utilized in the process of method development using central composite design approach. The saturation time was established at 10 minutes, and the ultraviolet detection was performed at a wavelength of 237 nm. The value 0.82 was discovered to be the retention factor (Rf ) for empagliflozin. The method was linear, precise and accurate over the entire concentration range examined (100-600 ng band-1), along with correlation coefficient value of 0.992. The proposed method is quick and selective, and a straightforward method of sample preparation and analysis for empagliflozin in its bulk and commercially available dosage forms. The stability of the drug was tested under a variety of different stress conditions in accordance with ICH guidelines, and the results obtained from the force degradations indicate that the developed method is appropriate for stability studies. [ABSTRACT FROM AUTHOR]