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Novel, simple, accurate and reliable Reverse Phase High-Performance Thin-Layer Chromatographic (RPHPTLC) method for analysis of Agomelatine (AGM) in bulk and tablet formulation have been developed and validated. The method was reverse phase chromatography performed on RP-18 Silica gel F254S TLC plates, with methanol: water (80: 20 %, v/v) as mobile phase. HPTLC quantitation of AGM was done by TLC-densitometry at 276 nm. The quantitation by HPTLC method was performed over the concentration range of 500-3000 ng/band for AGM with a high correlation coefficient (R2 = 0.999). The HPTLC method resulted into a compact and well resolved band for AGM at retention factor (Rf) of 0.43 ± 0.02. The limit of detection and limit of quantification were found to be 5.85 ng and 17.73 ng for RP-HPTLC, respectively. The accuracy of the proposed method was determined by recovery studies and found to be 99.23 to 99.98%. The proposed method is applicable to routine analysis of AGM in bulk and tablet formulations. The proposed method was validated according to various ICH parameters like linearity, accuracy, precision, specificity, limits of detection and limits of quantification. [ABSTRACT FROM AUTHOR]

The greener “high-performance thin-layer chromatography (HPTLC)” methods for apremilast (APM) analysis in pharmaceutical products and biological fluids are not currently available in the literature. Accordingly, this study involves the development and validation of a rapid, simple, economical, and greener reversed-phase HPTLC methodology for the estimation of APM in prepared nanoparticles (NPs), nanoemulsion, and marketed tablets. The estimation of APM was conducted using “RP-18 silica gel 60 F254S HPTLC plates” as the stationary phase. The combination of ethanol/water (65:35, v/v) was used as the greener mobile phase for APM analysis. The greenness of the method was predicted using three different approaches, namely Analytical Eco-Score (AES), ChlorTox, and the Analytical GREENness (AGREE) approaches. The λmax = 238 nm was used for the APM detection. By contrasting its single band at Rf = 0.61 ± 0.01 with those of pure APM, the HPTLC peaks for APM in an prepared NP formulation, nanoemulsion, and marketed tablets were identified. In the concentration range of 100–700 ng/band, the proposed analytical methodology was linear. The values of AES, ChlorTox, and AGREE were determined to be 93, 0.66 g, and 0.89, respectively, demonstrated an outstanding greener profile for the existing method. The amount of APM in the tablet, NP formulation, and nanoemulsion was found to be 98.40, 101.60, and 99.37 %, respectively. According to the findings of validation tests and pharmaceutical analysis, the suggested analytical technique could be successfully applied for the routine examination of APM in marketed tablets and laboratory generated nanoformulations.

The greener "high-performance thin-layer chromatography (HPTLC)" methods for apremilast (APM) analysis in pharmaceutical products and biological fluids are not currently available in the literature. Accordingly, this study involves the development and validation of a rapid, simple, economical, and greener reversed-phase HPTLC methodology for the estimation of APM in prepared nanoparticles (NPs), nanoemulsion, and marketed tablets. The estimation of APM was conducted using "RP-18 silica gel 60 F254S HPTLC plates" as the stationary phase. The combination of ethanol/water (65:35, v/v) was used as the greener mobile phase for APM analysis. The greenness of the method was predicted using three different approaches, namely Analytical Eco-Score (AES), ChlorTox, and the Analytical GREENness (AGREE) approaches. The λ max = 238 nm was used for the APM detection. By contrasting its single band at R f = 0.61 ± 0.01 with those of pure APM, the HPTLC peaks for APM in an prepared NP formulation, nanoemulsion, and marketed tablets were identified. In the concentration range of 100–700 ng/band, the proposed analytical methodology was linear. The values of AES, ChlorTox, and AGREE were determined to be 93, 0.66 g, and 0.89, respectively, demonstrated an outstanding greener profile for the existing method. The amount of APM in the tablet, NP formulation, and nanoemulsion was found to be 98.40, 101.60, and 99.37 %, respectively. According to the findings of validation tests and pharmaceutical analysis, the suggested analytical technique could be successfully applied for the routine examination of APM in marketed tablets and laboratory generated nanoformulations. [ABSTRACT FROM AUTHOR]