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CHMP. Trajenta-Assessment Report-Committee for Medicinal Products for Human Use (CHMP) (Eur Med Agency, 2011). Baink, S., Kaisar, M. M. & Hossain, M. S. Development and validation of a simple and rapid UV spectrophotometer method for assay of linagliptin in bulk and marketed dosage form. Indian J. Nov. Drug. Deliv. 5(4), 221–224 (2013).
Linagliptin isn’t available as a specific method for analyzing in British pharmacopeia (BP) or the United States Pharmacopeia (USP). The Review of Research Literature has shown several articles for the determination of LNG in pharmaceutical forms, including the spectrophotometer in UV 3, 4, 5, also in VIS with chemical derivation using NQS (1,2-naphtho quinine 4-sulphonic acid sodium salt), vanillin 6 and picric acid 7 as a chromogenic reagents. Capillary Electrophoresis (CE) 8, and with high-performance liquid chromatography (HPLC) 9, 10, 11, 12, 13. Those methods are specificity and selectivity but they need more time, a lot of amount an expensive solvent and equipments. Barapatre, S. R., Ganorkar, A. V. & Gupta, K. R. Quality by design-based HPLC assay method development and validation of linagliptin in tablet dosage form. Eur. J. Pharm. Med. Res. 4(02), 486–494 (2017). Mai, X. L. et al. A capillary electrophoresis method for the determination of the linagliptin enantiomeric impurity. J. Sep. Sci. 43(24), 4480–4487 (2020).
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Dalal, A., Tegeli, V. & Waghmode, R. Development and validation of a simple and rapid UV spectrophotometeric method for linagliptin in bulk and marketed dosage form. Der. Pharma Chem. 14(2), 23–26 (2022). Ntoi, L. L. A. & Von Eschwege, K. G. Spectrophotometry mole ratio and continuous variation experiments with dithizone. Afr. J. Chem. Educ. 7(2), 59–92 (2017). The effect of prolonged heating time on this reaction was controlled by monitoring the color development at different time intervals (10–60min) at 70–75°C. Maximum absorbance values were gained at 35min (Fig. 3b). Stability of the reaction product Linagliptin—PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Linagliptin#section=Structures, Accessed 19 Jan 2022. Compact and Portable: Mini and lightweight design makes this 20W usb c power adapter a perfect travel companion, Handy for home, office, and on vacation. easy to take out or put inside your bag.
The researcher studied the suitable of PDAB volume in the range of 0.5–3mL, to find the suitable volume of PDAB reagent (5% w/v). So, the result had shown that the highest absorption intensity was achieved at a PDAB volume of 1mL then it decreased (Fig. 3b). Evaluation of HCl volume w/v): 1.25 g was dissolved in 25 mL of methanol with good shaking, and was freshly prepared. Analytical procedure Gurrala, S., Anumolu, P. D., Menkana, S., Gandla, N. & Toddi, K. Spectrophotometric estimation of linagliptin using ion-pair complexation and oxidative coupling reactions—a green approach. Thai J. Pharm. Sci. 44(4), 245–250 (2020). Linagliptin is a new oral antidiabetic agent. LNG isn’t available a specific analytical method in pharmacopeia. LNG has many articles that aim to assay LNG by HPLC, this method needs expensive solvents and specific equipments. So, this paper was described a new, simple analytical method depending in condensation reaction between LNG with PDAB as a chemical reagent for determination LNG in bulk and pharmaceutical dosage. The conditions of optimal conditions of this analytical research were studied and it was found that distilled water and methanol were the best solvents for both LNG and PDAB, 1mL of PDAB 5% as a derivative reagent with 2mL of HCl 37% as an acidic medium with heating to 70–75°C on a water bath for 35min to form the yellow Schiff base with a wavelength at 407nm and the stability of Schiff base formed for one hour. Validation of the proposed method was showed that this reaction has linearity 5–45μg/mL, according to the correlation coefficient R 2 = 0.9989 with percent recovery (99.46–100.8%) within an accepted criteria and RSD was less than 2%, so this proposed method has good accuracy and precision and high specificity. Rajbangshi, J. C., Alam, M. M., Hossain, M. S., Islam, M. S. & Rouf, A. S. S. Development and validation of a RP-HPLC method for quantitative analysis of linagliptin in bulk and dosage forms. Dhaka Univ. J. Pharm. Sci. 17(2), 175–182 (2018).Badugu, L. R. A validated RP-HPLC method for the determination of linagliptin. Am. J. Pharm. Tech. Res. 2(4), 463–470 (2012). Freeman, M. K. Efficacy and safety of linagliptin (tradjenta) in adults with type-2 diabetes mellitus. J Clin Pharm Ther. 36(12), 807 (2011).
Mourad, S. S., El-Kimary, E. I., Hamdy, D. A. & Barary, M. A. Stability-indicating HPLC-DAD method for the determination of linagliptin in tablet dosage form: Application to degradation kinetics. J Chromatogr. Sci. 54(9), 1560–1566 (2016). Sri, K. V., Anusha, M. & Reddy, S. R. A rapid RP-HPLC method development and validation for the analysis of linagliptinin bulk and pharmaceutical dosage form. Asian J. Pharm. Anal. 5(1), 16–20 (2015).Widely Compatibility: TEGELI PD 20W USB C Charger plug is compatible with iPhone 14/13/13 pro/13 pro max /iPhone 12 / 12 Pro / 12 Pro Max / 12 Mini / 11/11 Pro / 11 Pro Max / 11 Mini / 10/10 Max / iPhone 8 / iPhone 7 / iPhone 7 plus / iPhone 6s / iPhone 6, Samsung Galaxy S21 / Galaxy S21 + / Galaxy S21 ultra / Galaxy S20 / Galaxy S10 / Galaxy S9 / Galaxy S8 / Note / Tab / A series. Sri, K. V. V., Anusha, A. & Sudhakar, M. UV-spectrophotometry method for the estimation of linagliptin in bulk and pharmaceutical formulations. Asian J. Res. Chem. 9(1), 47 (2016). Furthermore, the molar ratio of this reaction was selected between LNG and PDAB it was (1:1) complex depending on two methods the Job of continuous variations and molar ratio. Chemical and Physical Properties of LNG: color and form: slightly hygroscopic, white to yellow solid. Melting Point: 190–195°C. Solubility: In water, 3.33mg/L at 25°C; soluble in methanol; sparingly soluble in ethanol. Stability: It is stable if stored as directed; avoid strong oxidizing agents 2.
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