http://localhost:8080/xmlui/handle/123456789/7557 Sun, 05 Apr 2026 17:40:45 GMT 2026-04-05T17:40:45Z http://localhost:8080/xmlui/handle/123456789/7563 Process Validation Of Cefpodoxime Proxetil Oral Suspension I.P. Joshi, Priya The aim of this work was to study process validation of cefpodoxime proxetil oral suspension I.P. Three initial process validation batches of same size, method, equipment and validation criteria were taken. The critical parameters involved in sifting, mixing, drying and filling were identified and evaluated as per validation master plan. All the instruments were calibrated as per standard operating procedures. Uniformity of blending was optimum in 60 minutes as standard deviation is between ±0.31 to ±0.37. Drying time of 60 min was suitable for obtaining moisture content within 0.3-.06%. The Drug content of reconstituted liquid suspension on day 1 and at day 7 were within the limits of 90% to 110%. The outcome indicated that data obtained by process validation of three batches provides high degree of assurance that manufacturing process of cefpodoxime proxetil oral suspension produces product meeting its predetermined specifications and quality attributes. For Full Thesis Kindly contact to respective Library Mon, 06 Jun 2011 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/7563 2011-06-06T00:00:00Z http://localhost:8080/xmlui/handle/123456789/7561 Process Validation of Solid Dosage Form - Tablet Rathwa, Minaxi The purpose of research was to study prospective validation of Cimetidine 400 mg tablet dosage formulation. Quality cannot be adequately assured by in-process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications. Therefore building of quality requires careful attention to a number of factors, such as the selection of materials, product and process design, control variables, in process control and finished product testing. Three initial process validation batches of same size, same equipment, method, material and validation criteria was taken. In solid dosage forms the film coating tablets was used because of the protect from light, temperature, moisture mask of undesirable taste or odour improves the appearance, provide tablets identity, facilitate swallowing and control and modify release of the drug. Film coating applied as a thin polymeric film to the surface of the tablet. The critical process parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication, compression stages and coating parameter were identified and evaluated as per validation plan. Film coating of tablet were evaluated for coating uniformity, coating process efficiency and surface roughness. The spray rate, atomization air pressure, distance of nozzle from tablet bed, inlet air temperature, pan differential pressure, pan speed and % solid content these affect the final film quality of coated tablets. Therefore based on results of process validation batch at each of the stages for the specified parameters it was summarized and concluded that with the prospective process validation for the Cimetidine 400 mg tablet produces the batches with no significant deviation and reported documented evidence, that process can be effectively produce a product which complies with the present specification and reproducible quality standards. For Full Thesis Kindly contact to respective Library Wed, 01 Jun 2011 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/7561 2011-06-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/7560 Development and validation of new analytical methods for estimation of drugs in their combined dosage forms and validation of gc method for estimation of diethylamine and 2 eha in ampicillin for injection MISTRI, JANKEE Objective of the research work was “Development and validation of new analytical methods for estimation of drugs in combined dosage forms and validation of available GC method for estimation of diethylamine and 2 Ethyl hexanoic acid”. Recently, a new combination product (Nuedexta Capsules, Marketed by Avanir Pharmaceuticals) containing dextromethorphan hydrobromide (DEX) USP 20 mg and Quinidine Sulphate (QUIN) USP 10 mg has been approved by USFDA in October 2010 and launched in January 2011. Only one method till date has been reported for simultaneous estimation of DEX and QUIN in biological fluid using Fluorescence Excitation Method. Hence, an attempt was made to develop simple, rapid, accurate and precise methods for simultaneous estimation of the both. Three methods viz., Simultaneous equation, Derivative and RP-HPLC methods have been successfully developed and validated for linearity, precision, accuracy, specificity, limit of detection and limit of quantification according to ICH guidelines. Simultaneous equation method was performed at 226 nm and 253 nm while first order derivative at 232.6 and 245 nm in methanolic 0.5 M HCL for DEX and QUIN respectively. RP-HPLC method was developed with hypersil C8 BDS column using Phosphate Buffer (20 mM) pH 5.5, methanol and acetonitrile in ratio of 50: 40: 10 as mobile phase pumped at flow rate of 1 ml/min at 221 nm. Beer’s law was obeyed in the range of 5 to 40 ppm for DEX and 2 to 16 ppm for QUIN with r2 0.9991 and 0.9997 for derivative method, 0.9997 and 0.998 for simultaneous equation and 10 to 50 ppm for DEX and 5 to 25 ppm for QUIN with r2 0.999992 and 0.999995 respectively for RP-HPLC method. All the three methods were successfully applied to synthetic mixture spiked with standard and % recovery was found within acceptable range, which indicates potential suitability of the method for routine analysis of pharmaceutical dosage forms. All the three methods have been validated for other parameters and from the results, it can be concluded that methods are considered as “valid”. An attempt was made to develop Q-Ratio Method, but due to very law absorbance at Isobestic point (at 25 ppm, it showed 0.117 A) and failure to obtain linearity on repetition, the method was not further exploited. And available GC methods for estimation of DEA and 2 EHA in ampicillin for injection are suitable(valid) for its intended use at Astral Pharmaceutical Industries, Vadodara, Gujarat. For Full Thesis Kindly contact to respective Library Wed, 01 Jun 2011 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/7560 2011-06-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/7558 Development and validation of uv spectrophotometric and rphplc Methods for simultaneous estimation of esomeprazole Magnesium trihydrate and naproxen in bulk and tablet dosage Form SUTHAR, JIGARKUMAR NA For Full Thesis Kindly contact to respective Library Thu, 01 Dec 2011 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/7558 2011-12-01T00:00:00Z