scholarly journals Validation of Quantitative HPLC Method for Bacosides in KeenMind

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Ashley Dowell ◽  
George Davidson ◽  
Dilip Ghosh

Brahmi (Bacopa monnieri) has been used by Ayurvedic medical practitioners in India for almost 3000 years. The pharmacological properties ofBacopa monnieriwere studied extensively and the activities were attributed mainly due to the presence of characteristic saponins called “bacosides.” Bacosides are complex mixture of structurally closely related compounds, glycosides of either jujubogenin or pseudojujubogenin. The popularity of herbal medicines and increasing clinical evidence to support associated health claims require standardisation of the phytochemical actives contained in these products. However, unlike allopathic medicines which typically contain a single active compound, herbal medicines are typically complex mixtures of various phytochemicals. The assay for bacosides in the British Pharmacopoeia monograph forBacopa monnieriexemplifies that only a subset of bacosides present are included in the calculation of total bacosides. These results in calculated bacoside values are significantly lower than those attained for the same material using more inclusive techniques such as UV spectroscopy. This study illustrates some of the problems encountered when applying chemical analysis for standardisation of herbal medicines, particularly in relation to the new method development and validation of bacosides from KeenMind.

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (04) ◽  
pp. 39-47
Author(s):  
R. S. M Patve ◽  
◽  
A. R. Shaikh ◽  
N Inamdar ◽  
K. Bhise

A simple rapid, accurate, precise and reproducible validated UV spectroscopy, RP-HPLC method was were developed for the determination of lenvatinib in bulk forms. The quantification was carried out using HiQSil 4.6 X 250 mm, 5μ, C8 column, run in isocratic way using mobile phase comprising of methanol: ammonium acetate buffer 30:70 by volume, pH-3.5 adjusted with orthophosphoric acid and a detection wavelength of 301mm, and injection volume of 20μL, with a flow rate of 1.0mL/min. The retention time of lenvatinib was found to be 4.383 min., the linearity range of the proposed method lies between 10-40 μg/mL (r²=0.9992). recovery studies were also carried out and mean % recovery was found to be 99.05 for lenvatinib. LOD and LOQ values for lenvatinib were found to be 0.992 and 2.79 respectively. The proposed method was statistically evaluated and may be applied for routine quality control analysis of lenvatinib in bulk.


Author(s):  
Bhushan A. Bhairav ◽  
Machindra J. Chavan

Simple, swift, selective and accurate UV and HPLC methods were developed and validated for estimation of sofosbuvir in bulk and marketed preparation. In the UV spectroscopy method mobile phase used was methanol in 70:30 ratio with a detection wavelength of 260nm and the assay value obtained was 99.36%. The method was validated as stated by ICH in Q2 R1 guidelines in which linearity was detected from 06-30µg/ml range with regression value of 0.999. In the accuracy, precision and robustness studies RSD were below 2%. In HPLC method, Cosmosil C18 (250mm×4.6ID, Particle size: 5µ) column was utilized with methanol: water (70:30) as mobile phase, 0.9ml/min of flow rate, 260nm detection wavelength for estimation of sofosbuvir. Assay value obtained using this optimized parameters was 99.77% with the time of retention of around 4.3 minutes. HPLC method was also validated as stated by ICH in Q2 R1 guidelines in which linearity was noticed to be in the span of 10-50µg/ml with 0.999 of regression coefficient. LOD and LOQ values of the optimized method were 0.5764 and 1.7468µg/ml. In the accuracy, precision, robustness studies the value of RSD was under 2%. The optimized HPLC method was also utilized for the force degradation study, in which it was found that sofosbuvir is susceptible to oxidative, acid, alkaline, photolytic and thermal degradation. From this study it can be concluded that the developed methods can be employed in the routine analysis for sofosbuvir estimation in bulk and marketed preparation and also to determine degradation of drug.


2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.


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