http://localhost:8080/xmlui/handle/123456789/7555 Sun, 05 Apr 2026 17:40:52 GMT 2026-04-05T17:40:52Z http://localhost:8080/xmlui/handle/123456789/8207 Development and Validation of UV Spectrophotometric and RPHPLC Methods for Estimation of Esomeprazole Magnesium Trihydrate and Naproxen in bulk & tablet dosage form Suthar, Jigarkumar Naproxen and Esomeprazole Magnesium Trihydrate are used in combination for treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The present work deals with two simple, precise and economical spectrophotometric methods and one RP-HPLC method for simultaneous estimation of Naproxen and Esomeprazole Magnesium Trihydrate in combination. In spectrophotometric method Simultaneous equation method was used. 271 nm and 302 nm were used as analytical wavelengths. Correlation coefficient was obtained as 0.998 and 0.999 for Naproxen and Esomeprazole Magnesium Trihydrate, respectively. Second method was first order derivative method. 269nm (ZCP of Esomeprazole Magnesium Trihydrate and 317 nm (ZCP of Naproxen) as detection wavelength were used for the estimation of Naproxen and Esomeprazole Magnesium Trihydrate, respectively. Correlation coefficients obtained were 0.9985 and 0.999 for Naproxen and EsomeprazoleMagnesium Trihydrate, respectively. For both the spectrophotometric methods Beer’s law was obeyed in the concentration range of 5-50μg/ml and 2-12μg/ml for Naproxen and Esomeprazole Magnesium Trihydrate, respectively. In RP-HPLC method efficient chromatographic separation was achieved on Phenomenex luna ODS C18 stationary phase (250mm X 4.6 mm i.d., 5 μm particle size) with simple mobile phase combination of methanol: water 65:35 (%V/V) in an isocratic mode at a flow rate of 1.2 ml/min at 302 nm. The retention time for Naproxen and Esomeprazole Magnesium Trihydrate was 3.78±0.06 min and 5.72±0.04 min, respectively. The calibration curve of Naproxen and Esomeprazole Magnesium Trihydrate was linear in the range of 5-30 μg/ml (r2=0.9994) and 0.2-1.2 μg/ml (r2=0.9991), respectively. Proposed methods were validated as per ICH guidelines for linearity, accuracy, precision and specificity for the estimation of Naproxen and Esomeprazole Magnesium Trihydrate in combination. All three methods were compared statistically using ANOVA test. The results were found to be satisfactory, shows the methods can be used successfully in marketed formulations. For Full Thesis Kindly contact to respective Library Sun, 01 Jan 2012 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/8207 2012-01-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/8206 Development and Validation of UV Spectrophotometric and RP-HPLC Methods for Estimation of Aliskiren Hemifumarate and Valsartan in bulk and Pharmaceutical Dosage Form Gorwadia, Hitesh A First order derivative spectroscopy and RP-HPLC methods were developed and validated for simultaneous estimation of Aliskiren hemifumarate and Valsartan in bulk and synthetic mixture. A simple and easy UV spectrophotometric method with good sensitivity has been developed for simultaneous quantification of aliskiren hemifumarate and valsartan. The method employed First order derivative method based on the measurement of absorbance at two wavelengths, 280 and 255 nm, ZCP of Aliskiren hemifumarate and valsartan, respectively. The calibration curve was linear in a concentration range of 8-26 μg/ml for Aliskiren hemifumarate and 6-24 μg/ml for valsartan. The RP-HPLC method has shown adequate separation of Aliskiren hemifumarate and valsartan in bulk and its synthetic mixture. The separation was achieved on a Phenomenex luna ODS C18 (250mm X 4.6 mm i.d., 5 μm particle size) with an gradient system of Water: Methanol in the ratio of 60:40 v/v. The mobile phase at a flow rate of 1.0 ml/min, Injection volume 20μl andwavelength of detection used was 250nm. The retention time for Aliskiren hemifumarate and valsartan was obtained as 1.843±0.1min and 3.197±0.2min, respectively. The linearity of the proposed method was investigated in the range of 5-25μg/ml and 5-25μg/ml for Aliskiren hemifumarate and valsartan, respectively. Correlation coefficient was 0.998 and 0.999 for Aliskiren hemifumarate and valsartan, respectively. The developed method was validated as per ICH guideline, for its accuracy, precision, LOD & LOQ and the results were found to be satisfactory, thus the method is specific, rapid and simple with good sensitivity for estimation of Aliskiren hemifumarate and valsartan. These analytical methods are also applicable in ordinary laboratories . It can also be adopted for quality control tests for these drugs in tablets. For Full Thesis Kindly contact to respective Library Sun, 01 Jan 2012 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/8206 2012-01-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/8205 Process validation of Pantoprazole and Rabeprazole Lyophilized Product Desai, Avni Since process validation is essential for fulfillment of regulatory requirements and quality, the prospective validation of the new manufacturing process of lyophilized Pantoprazole and Rabeprazole injections I.P was carried out. Three initial production batches of the same batch size, method and equipment and validation criteria were taken. The critical parameters involved in manufacturing like environmental condition, sterilization process, filtration, filling, sealing and unloading were identified and evaluated as per process validation protocol. All the instruments were calibrated and equipments were validated as per standard operating procedure. The RSD for content uniformity was optimum in the batch as it was below 6% and the drug content of reconstituted powder was within the limit i.e. 85% - 115% for both Pantoprazole and Rabeprazole. The critical parameters and conditions were under prescribed control during the manufacturing processes. The outcome showed that the data obtained by process validation of three batches of Pantoprazole and Rabeprazole provided high degree of assurance that all the process variables were optimized and meets the proposed criteria. The lyophilized pantoprazole and Rabeprazole for injection were found to meet their predetermined specifications and quality attributes. For Full Thesis Kindly contact to respective Library Sun, 01 Jan 2012 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/8205 2012-01-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/8204 Stability Indicating RP-HPLC Method Development and Validation for Psychostimulant Drugs in Syrup Dosage Form Patel, Krupaben A Stability Indicating RP-HPLC method was developed and validated for estimation of Psychostimulant drugs in syrup dosage form. The RP-HPLC method has shown adequate separation of drug A from its degradation products. The separation was achieved on an Inertsil ODS C18 (250mm X 4.6 mm i.d., 5 μm particle size) with an isocratic mixture of 0.5 M Tetrabutyl ammonium hydrogen sulphate buffer pH 6.0 adjusted with glacial acetic acid: acetonitrile in the ratio of 90:10 v/v. The mobile phase at a flow rate of 1.0 ml/min, Injection volume 20μl and wavelength of detection was kept at 270nm. The retention time for Drug A was 4.235±0.1min. The linearity of the proposed method for drug A was investigated in the range of 1-75μg/ml and correlation coefficient was 0.9985. The limit of detection was 0.059μg/ml and the limit of quantification was 0.180μg/ml. Force degradation study was carried out on reference/working standard and syrup dosage form as per ICH guideline and it was exposed to hydrolytic (acid and base hydrolysis), oxidative, thermal and photo degradation conditions to apply stress. Proposed methods were validated as per ICH guidelines for linearity, accuracy, precision, specificity and robustness for estimation of drug A in commercially available syrup dosage form and results were found to be satisfactory. Thus the developed and validated stability indicating method can be used successfully for marketed formulations. For Full Thesis Kindly contact to respective Library Sun, 01 Jan 2012 00:00:00 GMT http://localhost:8080/xmlui/handle/123456789/8204 2012-01-01T00:00:00Z