Posted by admin on Jul 1, 2012 in |
Process Validation is a very common term in the pharmaceutical industry. But it involves series of activities carried out in order to have the assurance that the desired quality products are manufactured. The manufacturing process need to be controlled and for this one should have sound knowledge and understanding regarding the process as well as the product. Each and every step should be scientifically planned and conducted and documented appropriately in order to have an effective and efficient program. So here we discuss the Prospective Process validation of the Sotalol Hydrochloride 40 mg tablets, the critical process parameters involved in the manufacturing process and the consistency in the results of the three consecutive...
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Posted by admin on Jul 1, 2012 in |
This research manuscript describes simple, sensitive, accurate, precise and repeatable UV spectroscopic method for the simultaneous determination of Metronidazole (MET) and Ofloxacin (OFL) in suspension dosage form). Metronidazole has absorbance maxima at 318.0 nm and Ofloxacin has absorbance maxima at 294 nm in Methanol and Water (50:50) solvent. The linearity was obtained in the concentration range of 1-13 μg/ml for Metronidazole and 1-13 µg/ml for Ofloxacin with mean accuracies 99.73 ± 0.05 and 99.13 ± 0.41 for Metronidazole and Ofloxacin, respectively. This paper presents a useful UV spectroscopic method for validating equipment cleaning procedures and verifying cleaning in a pharmaceutical plant. The study summarizes the initial steps that should be taken into account and focuses particularly on the solutions to some of the most critical considerations (e.g., detection and quantification limits, recovery). Cleaning validation is the process of assuring that cleaning procedures effectively remove the residue from manufacturing equipment/facilities below a predetermined level. This is necessary to assure the quality of future products using the equipment, to prevent cross-contamination,...
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Posted by admin on Jul 1, 2012 in |
A Simple, Sensitive, Precise, and specific reverse phase high performance liquid chromatographic method has been developed for the determination of lymecycline in pharmaceutical Dosage Forms. Chromatographic separation was achieved on a PLRP-S (250×4.6 mm), 8.0 µm make: Varian column with a 11.5:10:20:1:57.5 mixture of 2-Methyl-2-propanol,3.5% w/v di-potassium hydrogen phosphate, 1.0% w/v Tetra butyl ammonium hydrogen sulphate, 4.0% w/v di -sodium edetate and JT Baker water as mobile phase, detection was at 254 nm. Response was a linear function of concentration in the range 5-0.02 mg/L for lymecycline; correlation coefficient was 0.9998, respectively. LOD and LOQ for lymecycline were found 0.02 mg/L and 0.05 mg/L. Accuracy (recoveries 95-97%) and reproducibility were found to...
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Posted by admin on Jul 1, 2012 in |
Cissus quadrangularis L. (Vitaceae) is a common perennial climber also called Asthisamhara meaning bone setter is prescribed both in Ayurveda as well as Unani systems for its medicinal use. Pharmacognostic evaluation of Cissus quadrangularis stem revealed a stomatal index of 151 with Stephanocytic stomata in the epidermal peeling. The anatomical section of the stem showed deposits of characteristic acicular or needle shaped calcium oxalate crystals, raphides and intrafasicular cambium. The histochemical studies showed the presence of alkaloids, tannins, phenols and suberin. The phytochemical analysis of aqueous, petroleum ether and dichloromethane extracts were positive for alkaloids, phenol, steroids, flavanoids in all the extracts. The presence of sclerides, fiber sclerides epidermal cells, phloem with companion cells, ray fibers with pits, raphides, acicular and sand crystals of calcium oxalate were evident in powder analysis. Under 365nm UV green fluorescent emission was observed in acetic acid and methanol treated stem...
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Posted by admin on Jul 1, 2012 in |
The Barleria prionitis Lin. (Acanthaceae), known as Vajradanti & Porcupine flower, is widely used in traditional medicine. According to survey, any report was not available on microscopic and physicochemical properties of Barleria prionitis Lin. The present study deals with Pharmacognostical examination and physicochemical constant of Barleria prionitis Lin. leaf. The leaf has antiseptic properties, its decoction is used for febrile catarrh, mouth wash to relief toothache and as a paste it is applied over boils & glandular swellings. Pharmacognostical evaluation includes macroscopy, microscopy, surface preparation and physicochemical parameter. The macroscopic features of the leaves are opposite, acute apex, elliptic-ovate in shape, entire margin, long petiole. Microscopically it consists of single layer of epidermis. Lamina is uniformly flat with even surface & contains single layer of palisade cell. Collateral vascular bundles and cross celled stomata. Physicochemical studies like ash value, loss on drying and extractive value. These finding will be useful towards establishing pharmacognostic standards which help in identification, purity and classification of the...
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