Posted by admin on Nov 1, 2014 in |
A simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for simultaneous estimation of Cinnarizine and Dimenhydrinate in Tablet Dosage Form. Chromatography was performed on a PhenomenexPartisil ODS C18 (250 X 4.6 mm) 5mm column using Acetonitrile: Water (90:10) as a mobile phase. The detection of the synthetic mixture was carried out at 265 nm with a flow rate of 0.7 ml/min. The retention times were 4.3 and 5.8 minutes for Cinnarizine and Dimenhydrinate, respectively. Proposed method was validated as per ICH guidelines for linearity, accuracy, precision; specificity and robustness for estimation of Cinnarizine and Dimenhydrinate in Tablet Dosage Form and results were found to be satisfactory. The linearity of the method was excellent over a concentration range 20-100μg/ml for Cinnarizine and 40-200μg/ml for Dimenhydrinate. The correlation coefficient was 0.996 and 0.992 for Cinnarizine and Dimenhydrinate, respectively. The limit of detection was 1.62μg/mL and 2.62μg/mL for Cinnarizine and Dimenhydrinate, respectively. The limit of quantitation was 4.93μg/mL and 7.95μg/ml for Cinnarizine and Dimenhydrinate, respectively. The...
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Posted by admin on Nov 1, 2014 in |
Biobatch is usually prepared for the purpose of pharmacokinetic evaluation before NDA or IND filing. There are several critical issues that one has to face during the audit process like equivalence between the Biobatch and proposed commercial production batch. During the development and scale-up of the manufacturing process, various standard operating processes have to be documented to provide link between the bio/clinical batch and commercial batch. The Biobatch is a key component of the quality assessment, regardless of whether there is a bio waiver supported by dissolution studies or a formulation comparison, or bioequivalence study. IVIVC is one of the methods accepted by regulatory authorities including USFDA and it is applied while preparing the Biobatch. Extensive pilot experiments are to be carried out before a Biobatch is prepared. This may increase the cost of production for the company. Further, even after the approval of the formulation, various pharmaceutical factors may vary and lead to inconsistencies during the production phase. Recently, to overcome these problems, several software are available. Judicious...
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Posted by admin on Nov 1, 2014 in |
The author selected and developed a new simple, sensitive and reproducible spectrofluorimetric method and validated for the determination of Memantine Hydrochloride in bulk as well as pharmaceutical formulations depending on condensation of Memantine hydrochloride with 1, 2 – Naphthoquinone -4- sulphonate (NQS) in an alkaline medium to become a product with orange color. The spectrofluorimetric method involved reduction of the product with potassium borohydrate and the later measurements of fluorescent formed lessen the NQS product after excitation at 295 nm and emission wavelength at 385 nm for the spectrofluorimetric method under optimum conditions, linear relationship with best correlation coefficient 0.9999 and the linearity was detected in between the range of 0.25-1.25 µg/mL. The mean accuracy was found to be 99.57 % to 99.66 %. The intraday and interday precision was found to be 0.14-0.16 % and 0.13-0.15% respectively. The limit of detection was found to be 0.0090µg/mL and the limit of quantification was 0.0270µg/mL. Therefore this newly recommended spectrofluorimetric method is most suitable for estimation of Memantine and observed...
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Posted by admin on Nov 1, 2014 in |
One of the prime candidates in the treatment of debilitating human cancers includes a family of enzymes referred to as L- glutaminases. The antitumor activity of these enzymes found effective in countering Acute Lymphoblastic Leukemia (ALL a commonly diagnosed pediatric cancer.). Further it is found to inhibit four human tumour cell lines namely Hep-G2 [Human hepatocellular carcinoma cell line], MCF-7 [Breast cancer cell line], HCT-116 [Colon cell line] and A549 [Human lung Carcinoma]. Apart from therapeutic use, it is having a number of other applications like in food industry, analysis and in production of fine chemicals. This review, hence, mainly focuses on the biochemical aspects of L-Glutaminase production, aiming to comprehend the physiochemical characteristics, application of L-Glutaminase and its properties. Processes central to these biochemical aspects, including submerged fermentation and Solid state fermentation of L- glutaminase producing organisms are also...
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Posted by admin on Nov 1, 2014 in |
Averrhoa carambola -L. (Oxalidaceae) has great importance in the Indian traditional system of medicine for controlling diabetes and piles: the combined extracts of leaves as well as fruits of A. carambola are used for the treatment of jaundice, gastric problems and other chronic conditions as well as in food supplements.The objective underlying this experiment is to determine the safety profile of the plant used on a daily basis as well as for prolonged exposure to subjects. In this study, we analyzed the influence of ethanol extract of Averrhoa carambola at a dose level of 2000 mg kg-1 bw on the acute and with a graded dose levels from 250, 500, 1000 and 2000 mg kg-1 bw for 28-day repeated-dose toxicity test in Wistar rats.The analysis revealed that the repeated oral dose of Averrhoa carambola L. at a dose level upto 2000 mg kg-1 bw for 28 days did not induce any biochemical, hematological, morphological, histopathological signs of toxicity. High dose of Averrhoa carambola L. extract did not inhibit the...
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