Development and Validation of Stability Indicating Uv and Rp-Hplc Method for the Estimation of Flupritine Maleate in Bulk and Formulations

The objective of the study was to develop stability indicatingUV spectroscopy and RP-HPLC method for the estimation of flupritine maleate in bulk and marketed tablets. Chromatographic separation was achieved on Agilent Eclipse C18, 150 x 4.6 mm, 5m with mobile phase consisting of Buffer(1 ml OPA and...

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Veröffentlicht in:Oriental journal of chemistry 2014, Vol.30 (4), p.1933-1940
Hauptverfasser: Gowrisankar, D, Rao, N
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container_end_page 1940
container_issue 4
container_start_page 1933
container_title Oriental journal of chemistry
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creator Gowrisankar, D
Rao, N
description The objective of the study was to develop stability indicatingUV spectroscopy and RP-HPLC method for the estimation of flupritine maleate in bulk and marketed tablets. Chromatographic separation was achieved on Agilent Eclipse C18, 150 x 4.6 mm, 5m with mobile phase consisting of Buffer(1 ml OPA and 1 ml TEA in 1000 ml water and pH was adjusted to 3 with dilute OPA) and Methanol are taken in 50:50%v/v. The effluent was monitored at 246 nm. A sharp peak was observed at 4.0 min. UV Spectrophotometric method was performed at 250 nm using methanol as the solvent. R2=0.999 for HPLC method and R2=0.998 for UV Spectrophotometric method. The method was validated as per ICH guidelines with linearity, precision, accuracy, robustness, ruggedness and specificity.Statistical analysis showed that both the methods were precise, accurate, sensitive, and Stability indicating can be used for the routine analysis of flupritine economically in bulk and commercial formulations.
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subjects Accuracy
Analgesics
Calibration
Drug dosages
Economic analysis
Formulations
High performance liquid chromatography
International conferences
Linearity
Methanol
Methods
Pharmaceuticals
Ruggedness
Solvents
Spectrophotometry
Stability analysis
Statistical analysis
Tablets
title Development and Validation of Stability Indicating Uv and Rp-Hplc Method for the Estimation of Flupritine Maleate in Bulk and Formulations
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