1. DEVELOPMENT AND VALIDATION OF SIMPLE RP-HPTLC METHOD FOR ESTIMATION OF AGOMELATINE IN BULK AND PHARMACEUTICAL FORMULATION.
- Author
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Chaure, Vinod A., Patil, Ravindra R., Gomase, Pravin V., Ansari, Imtiyaz T., Kuwar, Rajesh, Yaasir, Ansari, Patil, Kamini Ravindra, and Kokani, Manesh Bharat
- Subjects
HYDROCHLOROTHIAZIDE ,DETECTION limit ,RF values (Chromatography) ,SILICA gel ,STATISTICAL correlation - Abstract
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]
- Published
- 2024
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