Current Issue : January - March Volume : 2014 Issue Number : 1 Articles : 10 Articles
The present study was carried out to determine the heavy metals concentration in five different estuarine fishes from\r\npichavaram mangrove forest-Tamil Nadu, southeast coast of India. Heavy metals concentration range varied from species to\r\nspecies. The analysis of the selected metals in the present study revealed in order of Mn < Cr < Cd < Co < Cu in almost all the\r\nspecies and the concentration of metals in the fishes followed in an order of S. Canaliculatus < S. argus < L. tade < T. puta < S.\r\nsihama < S. indicus, more or less for all the heavy metals. The highest concentration of copper was found in S. indicus whereas the\r\nlowest concentration was found in S. canaliculatus and similarly the chromium concentration was found maximum in S.\r\ncanaliculatus and minimum in S. sihama. Manganese, cobalt and cadmium concentration was found minimum in S. indicus while\r\nthe maximum of these metals were found in S. argus, S. sihama and S. canaliculatus repectively....
This work comprises two parts. In the first part, three chemometric assisted spectrophotometric techniques namely;\r\nclassical least-squares (CLS), principal component regression (PCR) and partial least-squares (PLS) were applied for the\r\ndetermination of binary mixtures containing candesartan cilexetil (CND) and hydrochlorothiazide (HCZ) in methanol. In the\r\nsecond part, a precise and stability-indicating RP-HPLC was developed for the determination of CND and HCZ in ternary mixture\r\nwith candesartan cilexetil degradation product (CDP) using indapamide (IND) as an internal standard. The chromatographic\r\nseparation was carried out on a C18 column (250 mm x 4.6 mm, 5?m) using a mobile phase consisting of acetonitrile: potassium\r\ndihydrogen phosphate (40 mM, adjusted to pH 8.5 with potassium hydroxide) (48:52 v/v) with 0.1% triethylamine in each\r\ncomponent as ion pairing agent. Flow rate was maintained at 0.9 ml min-1 while UV detection was carried out at 260 nm.\r\nLinearity, accuracy and precision were found to be acceptable over the concentration ranges of 3.2ââ?¬â??13.2 ?g ml?1 and 2.5ââ?¬â??10 ?g\r\nml?1 for CND and HCZ, respectively in case of chemometric methods as well as 6.4 ââ?¬â?? 41.6 ?g ml-1 and 5 ââ?¬â?? 32.5 ?g ml-1 for CND and\r\nHCZ, respectively in case of the LC method. The Validated methods proved to be specific, robust and accurate for the quality\r\ncontrol of the cited drugs in pharmaceutical preparations....
Business success is the extent to which an organization can produce a higher quality product or service than the\r\ncompetitors are able to at a competitive price. The quality of products strongly influences the success of any pharmaceutical\r\nfirm. Quality cannot be tested but rather must be built-in by design, as recommended by the FDA. Now-a-days quality issues can\r\nbe controlled by various GMP (i.e. Good Manufacturing Practices) systems and with the use of advanced technologies. This\r\narticle aims at providing a gist on the emerging and much important concepts in the branch of quality assurance techniques. The\r\nconcepts of PAT (Process Analytical Technology), CAPA (Corrective Actions and Preventive Actions), HACCP (Hazard analysis\r\nand critical control points), GAMP (Good Automated Manufacturing Practice) and GEP (Good Engineering Practices) have been\r\ncovered here....
Present study was planned to evaluate the performance of effluent treatment plant (ETP) of pharmaceutical industry\r\n(Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India) for a period of 30 days. ETP was functioning to remove the\r\nsuspended and dissolved solids and toxic compounds from the waste water before it released into a water body. Reduction of\r\npollutant in the waste water down to permissible concentration is necessary for the protection of ground water and\r\nenvironment. Performance assessment was evaluated by monitoring waste water at time period of 30 days. The waste water\r\nsample were collected from the six points viz., equalization tank, aeration tank I, II, III, IV and holding pond of industry. The\r\nparameters such as pH, chemical oxygen demand (COD), biochemical oxygen demand (BOD), total suspended solids (TSS) and\r\ntotal dissolved solids (TDS) were analyzed. Moreover, mixed liquor suspended solid (MLSS), mixed liquor volatile suspended\r\nsolid (MLVSS), sludge volume index (SVI) and turbidity were also checked. The results of present studies revealed that, all the\r\nparameters were found within the prescribed permissible limits of Madhya Pradesh Pollution Control Board (MPPCB), Bhopal\r\nthat indicates the better efficiency of the industry....
Marketed pharmaceutical preparations containing alcohol (herbal origin and allopathic) may affect the health of\r\npatients on faulty dosing. Hence the present work aimed to estimate the alcohol contents by gas chromatographic technique and\r\nto set the method for routine quality and safety standardisation with well-founded technical support. In present work, alcohol\r\nfrom representative preparations was separated by distillation method. The method was set up for the quantitative estimation\r\nof alcohol by gas chromatography. The method was developed by changing the various parameters of gas chromatography.\r\nFurthermore the method was validated in order to confirm its reliability and potentials to use as quality control tool in QC\r\nlaboratories. In ayurvedic preparation asava, the content of alcohol (as self generated alcohol) was found between 10.00 to\r\n11.50 % v/v, while in mouthwash it was 9.90 to 10.78 % v/v, which was found to obey the label claim. The preparations were\r\nsatisfying the said quality standards as the alcohol content found by gas chromatographic analysis method was within\r\npermissible limits. The marketed preparations selected for the present investigation were found to contain the alcohol contents\r\nwithin limits as per labelled claim. The developed method satisfies all parameters for validation as per ICH guidelines....
Advanced analytical techniques play a crucial role in the pharmaceutical field. Over two decade�s capillary\r\nelectrophoresis (CE) has emerged as a powerful analytical technique. Many hyphenated techniques are available which are fast,\r\ninexpensive and have low detection limit. In this context, capillary electrophoresis-diode array detection (CE/DAD) has\r\nattracted attention in peak purity determination, metabolomics and analysis of wide range of drugs. CE-DAD has the potential\r\nfor wide acceptance in the future. Here, recent method developments and applications of CE-DAD relevant to pharmaceuticals\r\nare reviewed and discussed to show actual developments and future prospects. Based on other reviews on related subjects\r\ncovering large parts of previous works, the paper is focused on general ideas and contributions....
Now days the demand for higher production and lowering of operating costs has led to the use of continuous\r\nchromatographic processes. The application of counter current operation to batch chromatography resulted in the first\r\ncontinuous counter current chromatography i.e. simulated moving bed chromatography. It is originated from true moving bed\r\ntechnology. To minimize the difficulties in true moving bed technology i.e. real movement of solid bed of adsorbent as well as\r\nsmall life time of adsorbent due to attrition, an alternative to counter current flow, simulated moving bed (SMB) process has\r\nbeen developed. This technique is a variant of high performance liquid chromatography. It is used to separate particles\r\nor chemical compounds that would be difficult or impossible to resolve. Counter current flow enhances the potential for\r\nseparation and hence makes the SMB process more efficient. With SMBC, a series of small columns is used instead of one large\r\ncolumn, 50-70% of the solid phase is engaged in the separation zone, while the rest of the column material is being prepared for\r\nthe next cycle of purification provides higher recovery and purity. Moreover, SMBC provides essentially an infinite column bed\r\nlength without the costs associated with obtaining, operating and maintaining....
New feasible, sensitive, rapid and economic spectrophotometry method has been developed for the simultaneous\r\nquantitative determination of Berberine (BER) and Curcumin (CUR). The plant extract mixtures and polyherbal formulation was\r\nestimated with the help of first derivative zero crossing spectrophotometry method. BER and CUR showed maximum\r\nabsorbance at 307 nm and 428.5 nm and obeyed Beerââ?¬â?¢s law in the concentration range 15-40 ?g/ml and 1-6 ?g/ml respectively.\r\nThe method was validated in terms of linearity (R2=0.997, 0.998), precision in terms of % relative standard deviation (R.S.D.) for\r\nintraday and interday of BER and CUR was within limit (0.184%ââ?¬â??0.617% and 0.141%-0.661% respectively), accuracy (within\r\nthe limit), LOD and LOQ (0.029, 0.047 and 0.089, 0.141) and specificity. The methods were found to be robust to variation in\r\nabsorbance due to variation in wavelength (?max Ã?± 2.0). By this method, C. longa and T. cordifolia showed 4% w/w curcumin and\r\n0.2% w/w berberine respectively in combined methanolic extracts of the two herbal drugs. This method was simple, precise,\r\naccurate, sensitive and reproducible and can be used for the routine quality control testing for the marketed polyherbal\r\nformulations and standardization of both plants (Tinospora cordifolia and Curcuma longa)....
Five simple, accurate, sensitive and economical UV spectrophotometric methods (A-E) have been developed and\r\nsubsequently validated for the determination of avitriptan in bulk and pharmaceutical formulations. The methods were based\r\non the formulation of colored complex of avitriptan with different reagents. The absorbance of the formed color complex is\r\nmeasured at the wavelength of maximum absorbance of the complex against the reagent blank. Method A is based on the\r\nformation of oxidative coupling reaction involving the use of iron (III) ââ?¬â?? MBTH (3-methyl-2-benzo thiozolinone hydrozone\r\nhydrochloride). The resulting green colored chromogen complex absorbs at max = 500 nm. Method B is based on the reaction of\r\navitriptan with ferric chloride and K3[Fe(CN)6] to form a green colored species having absorption maxima at max =760 nm.\r\nMethod C is based on the reaction of avitriptan with FeCl3 and 1,10-phenanthroline to form a blood red colored chromogen,\r\nexhibiting absorption maxima at max = 610 nm. Method D is based on the formation of oxidative coupling of drug with brucine\r\nin the presence of sodium meta periodate a purple red colored species is found and exhibit absorption maxima at max = 610 nm.\r\nMethod E is based on the formation of complex with acidic dye WFB BL having absorption maxima at max = 620 nm. All these\r\nmethods have different linearity ranges. Statistical analysis proves that the proposed methods are reproducible and selective for\r\nthe estimation of avitriptan in bulk drug and in its tablet dosage form....
This study summarizes the development and validation of stability-indicating assay methods (SIAMs). A systematic\r\napproach for the development and validation of stability-indicating methods is discussed. Forced degradation is also discussed\r\nto some extent which is a powerful tool used routinely in pharmaceutical development in order to develop stability indicating\r\nmethods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug\r\nproducts. Force degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of\r\npharmaceutical development. This article describes how to develop a stability indicating method and their regulatory aspect....
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