New Stability-Indicating Ultra Performance Liquid Chromatography Method Development and Validation of Lenvatinib Mesylate in Bulk Drug and Pharmaceutical Dosage Forms

Abstract

Objective: The objective of the present study was to develop and validate a new stability-indicating method for the quantification of lenvatinib mesylate in bulk drug and pharmaceutical dosage form using ultra performance liquid chromatography (UPLC).Methods: The optimized chromatographic conditions for elution of drug included UPLC HSS C18 (100 mm × 2.1 mm, 1.8 m) column, mixture of 0.1% orthophosphoric acid and acetonitrile (50:50 v/v%) mobile phase run on an isocratic mode at a flow rate of 0.3 mL/min, 240 nm detection wavelength, and column oven temperature maintained at 30°C.Results: The retention time for lenvatinib was found to be 1.24 min. The developed method was validated for various validation parameters in accordance with the International Conference on Harmonization guidelines. The method obeyed Beer’s law in the concentration range of 2.5– 15 μg/mL with a correlation coefficient of 0.9996. The percentage relative standard deviation and percentage recovery were determined to be 0.4 and 99.66–100.30%, respectively. The developed method was found to be accurate, precise, specific, linear, rugged, and robust. Forced degradation studies were conducted by exposing the drug to diverse stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was obtained within the limits.Conclusion: The developed method for the estimation of lenvatinib can be employed to routine analysis of pharmaceutical dosage form.

Stability Indicating RP-HPLC for Quantification Mangiferin in Extract of Three Species Mango Leaves

“…The force degradation studies were conducted by exposing the standard and sample solution with various degradation conditions such as acidic (2 N HCl for 30 min at 60 °C), basic (2 N NaOH for 30 min at 60 °C), neutral (refluxing the extract in water for 6 hours at 60 °C), oxidative (20 % H 2 O 2 for 30 min at 60 °C), thermal (105 °C for 6 h ), and photolytic (UV chamber for 7 days ) (Naim, et. al., 2018, Bandla, et al, 2018.…”

A sensitive bioanalytical method development and validation of afatinib in human plasma by LC-ESI-MS/MS

“…Afatinib dimaleate1-4 is chemically known as (Z)-but-2-enedioic acid;(E)-N-[4-(3chloro-4-fluoroanilino)-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino) but-2-enamide. Its molecular formula is C32H33ClFN5O11 and its molecular weight is 718.083g/mol (Kawada I et., al 2008, Schiller JH et., al 2002, John T et ., al 2009, Olivier Bouche et., al 2011, Jahnavi Bandla et., al 2018.It is white to brownish-yellow powder and soluble in water. It has pKa values of 8.81 and 12.49.…”

Development of Green RP- and Green NP-HPTLC Methods for Estimation of Lenvatinib and Comparative Evaluation by AGREE

“…It is white to pale reddish-yellow powder, slightly soluble in water and sparingly soluble in ethanol, isopropyl alcohol, and methanol. It has a pKa value of 5.05, and its molecular weight is 523 gm/mol …”

“…Reversed-phase HPTLC (RP-HPTLC), for instance, was used to develop a sensitive, fast, and accurate technology for separating and determining analytes in a variety of pharmaceutical compounds and pharmaceutical formulations. For the quantitative analysis of LNB, a few high-performance liquid chromatography (HPLC) techniques, a few ultrahigh-performance liquid chromatography (UHPLC) techniques, and a few LC–MS/MS studies in human serum are reported. ,− The majority of these methods were developed using acetonitrile (ACN), which is not regarded as a green solvent nor had a complicated mobile phase with low AGREE scores. The Green analytical HPTLC techniques have not been reported for the quantification of LNB that incorporates the use of GAC in bulk or marketed formulations, according to studies available in the literature.…”