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Patel, Vandana B.
- Validation of Water Treatment System for Pharmaceutical Dosage forms
Authors
1 Department of Quality Assurance, Baroda College of Pharmacy, Vadodara, Gujarat, IN
2 Bharat Parenterals Ltd., Vill. Haripura, Ta. Savali, Dist. Vadodara, Gujarat, IN
Source
Asian Journal of Research in Chemistry, Vol 4, No 10 (2011), Pagination: 1536-1538Abstract
Water is an essential ingredient of various pharmaceutical preparations and is also used to clean process equipment. It is, therefore, important that water should meet set standards given in official guidelines. In the present investigation, validation of water treatment system was performed to ensure that it constantly provides the specified quality and quantity of water so as to ensure that there is no contamination of the product or equipment. Validation of water purification system was performed in three phases by applying various chemical and microbiological tests as specified in official texts. The results were found to be shown satisfactory and within the specified limit.Keywords
Validation, Water Treatment System, Quality Standards, Chemical Tests, Microbiological Testing.- Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Pharmaceutical Tablet Formulation by Derivative Spectrophotometric Method
Authors
1 Baroda College of Pharmacy, Limda, Vadodara, Gujarat, IN
2 Department of Pharmacy, The Maharaja Sayajirao University of Baroda, Gujarat, IN
Source
Asian Journal of Research in Chemistry, Vol 4, No 1 (2011), Pagination: 128-131Abstract
Two simple, accurate and precise methods viz. first derivative zero crossing spectrophotometry (method 1) and derivative ratio spectra zero crossing method (method 2) have been developed for simultaneous determination of amlodipine besylate and atorvastatine calcium in pure and commercial formulation without any prior separation or purification. The linearity range was found to be 5- 40 μg ml-1 for both the drugs. The value of limit of detection and limit of quantification was 0.397 μg ml-1 and 1.323 μg ml-1 for amlodipine and 0.220μg ml-1 and 0.735 μg ml-1 for atorvastatine respectively for method 1 and 0.600 μg ml-1 and 0.262 μg ml-1 for amlodipine and 0.262μg ml-1 and 0.874 μ ml-1 for atorvastatine respectively for method 2. The method was satisfactorily validated in terms of accuracy and precision. The results of the study showed that the proposed spectrophotometric methods are useful for the routine determination of amlodipine and atorvastatin in its combined pharmaceutical tablet dosage form.
Keywords
First Derivative Zero Crossing Spectrophotometry, Derivative Ratio Spectra Zero Crossing Method, Amlodipine Besylate, Atorvastatin Calcium.- Simultaneous Determination of Levofloxacin and Ornidazole by Ratiospectra Derivative Spectrophotometry and High Performance Liquid Chromatography
Authors
1 Pharmaceutical Quality Assurance Laboratory, Pharmacy Department, The Maharaja Sayajirao University of Baroda, Vadodara-390001, Gujarat, IN
2 Baroda College of Pharmacy, P.O. Limda, Ta. Waghodia-391760, Dist. Vadodara, Gujarat, IN
Source
Asian Journal of Research in Chemistry, Vol 3, No 4 (2010), Pagination: 922-927Abstract
Rapid, precise, accurate and specific ratiospectra derivative spectrophotometry and high-performance liquid chromatography procedures were described for the simultaneous determination of levofloxacin and ornidazole in their combined dosage forms. For the first method of ratiospectra derivative spectrophotometry the signals were measured at 302 nm for ornidazole and 292.8 nm for levofloxacin as a mixture. The second method is based on high performance liquid chromatography (HPLC) on Princeton RP-C18 column (5μ, 150x4.6mm) using 0.1% v/v triethylamine-acetonitrile (80:20, v/v) (pH 6.0). Detection was carried out using a UV detector at 295 nm. The retention time for levofloxacin and ornidazole were found to be 2.8 min and 4.4 min respectively. Both the methods showed good linearity in the range of 1 to 20μg/mL and 5 to 5000ng/ml for ratiospectra derivative spectroscopy and HPLC respectively.
Pharmaceutical formulations containing both drugs were successfully assayed using the developed methods.