Development and Validation Stability Indicating HPTLC Method for Determination of Vildagliptin and Metformin Hydrochloride in the Pharmaceutical Dosage Forms

Abstract

Objective: A simple, precise, and accurate stability indicating high-performance thin layer chromatography method was developed and validated of vildagliptin (VIL) and metformin (MET) in pharmaceutical dosage forms. Methods:In the present study, system suitability test, stress study, alkali hydrolysis, acid hydrolysis, neutral hydrolysis, oxidative stress degradation, dry heat degradation, wet heat degradation, photodegradation study has been used. In this method, optimization by changing various parameters, such as organic solvent and the composition of the mobile phase, acid or base modifier used in the mobile phase; by varying one parameter and keeping all other conditions constant. 10 µl of the stock solution for MET (500 ng/band) and 2 µl of the stock solution for VIL (100 ng/band) were applied to TLC plates. The final solutions were applied on the HPTLC plates and these were developed as per the optimized densitometry conditions. Results:From the spectra, it was observed that MET and VIL exhibited good absorbance at about 217 nm. Both the drugs showed degradation with additional peaks at Rf values of 0.16 for MET and with Rf values 0.81 for VIL respectively. The method was validated for linearity, precision, accuracy, limit of detection, limit of quantification, ruggedness, specificity, and robustness. Good separation was achieved by using the mobile phase Hexane: Methanol: Acetonitrile: Glacial Acetic Acid (2:3.5:2.5:0.2 v/v/v/v) with retardation factor (Rf) values of 0.22±0.01 for MET and 0.73±0.02 for VIL. Conclusion:A validated HPTLC method was developed for the determination of metformin hydrochloride and vildagliptin. The method is simple, quick, and can be applied routinely for the analysis of these drugs from marketed dosage forms.

Various innovative UV spectroscopic methodologies for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

“…In patients with poor glycemic control following monotherapy, VGT is authorized in the European Union and internationally for the management of type 2 diabetes mellitus in conjunction with metformin, a sulfonylurea, a thiazolidinedione, or an SGLT2 inhibitor. Figure 1 provides the chemical structures of both the analytes (Boovizhikannan and Palanirajan, 2013;Donepudi and Achanta, 2019;Gundala et al, 2019).…”

“…Fixed dose combination consisting of DPZ (10 mg) and VGT (100 mg) formulated as tablets (sustained release that aids people with keeping blood sugar levels in check when suffering from type 2 diabetes) (Joshi et al, 2022;Orme et al, 2014;Sen et al, 2022;1mg.com, 2023). Ultra violet (UV) spectrophotometry (Attimarad et al, 2023;Banik et al, 2015;Manasa et al, 2014;Mante et al, 2017;Sen et al, 2023), high-performance liquid chromatography (Deepan and Dhanaraju, 2018;Gundala et al, 2019;Mante et al, 2018;Usman et al, 2020;Vankalapati et al, 2022), and high-performance thin layer chromatography (Abdelrahman et al, 2020;Ahmed et al, 2020;Bendale et al, 2018;Patil et al, 2020;Suma et al, 2019) were only some of the analytical methods described in the literature for determining DPZ and VGT concentrations in single and mixed dosage forms.…”

Method stability indicating method development and validation for emtricitabina by UV spectroscopic and RP-HPLC methods

“…Tests are carried out on freshly prepared solution of Emtricitabine with six replicates. [16][17][18][19][20][21][22][23][24] 2.4.1. Acid induced-degradation 10.0 mg Emtricitabine was transferred to 100.0 mL volumetric flask, added 50.0 mL mobile phase, sonicated for 20.0 min., volume was made up to the mark with mobile phase.…”

Development and validation of high‐performance thin layer chromatographic method for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

“…UV spectrophotometry [10–14], HPLC [3, 15–20], and high‐performance thin layer chromatography (HPTLC) [21–25] are among the analytical approaches stated in the literature for quantifying the concentrations of DPZ and VGT, either separately or in blend with other substances, in bulk drug samples or pharmaceutical formulations. Among the various methods reported, Attimarad et al.…”

“…UV spectrophotometry [10][11][12][13][14], HPLC [3, [15][16][17][18][19][20], and high-performance thin layer chromatography (HPTLC) [21][22][23][24][25] are among the analytical approaches stated in the literature for quantifying the concentrations of DPZ and VGT, either separately or in blend with other substances, in bulk drug samples or pharmaceutical formulations. Among the various methods reported, Attimarad et al (2023) [10] presented a study where they simultaneously determined DPZ and VGT in a combined formulation using three distinct UV spectroscopic methods.…”