Method Development And Validation Of Donepezil Hydrochloride By Using Uv Spectrophotometric Method

Abstract: Simple, specific, accurate and cost economic UV spectrophotometric methods weredeveloped and validated for determination of Donepezil Hydrochloride. Instead of usingorganic solvents, mixture of Acetonitrile and water was used during method development andvalidation. Donepezil hydrochloride standard solution was scanned in the UV range (400-200nm) in a 1cm quartz cell in a double beam UV spectrophotometer. The standard solution ofDonepezil Hydrochloride showed maximum absorption at wavelength 231 nm. The methodobeys Beer’s law in the concentration range from 4-20µg/ml. The correlation coefficient wasfound to be 0.9983and regression of the curve was found Y=0.0376x+0.0185 with excellentrecovery 99.66-100.83%. Limit of detection and limit of quantification were found to be0.197µg/ml and 0.6µg/ml respectively. The ruggedness and robustness were performed. Themethod was validated for several parameters like accuracy, precision as per ICH guidelines.Statistical analysis proved that the methods are repeatable and specific for determination ofthe drug. These methods can be adopted in the routine assay analysis of DonepezilHydrochloride in API and pharmaceutical dosage form.

U.V.Spectrophotometric Method development for Capecitabine in Eudragit and chitosan based Mecrospheres and its Validation.

A simple, rapid, accurate, precise, and economic Spectrophotometric method for Capecitabine in bulk and formulated microspheres dosage form has been developed. Capecitabine shows absorbance maximum at different wavelength in different solvents, so absorbance was measured and the same wavelengths used for the estimation of Capecitabine in respective solvents. Capecitabine obey the beer lamberts’ law. Method is validated according to ICH guideline and carried out for analysis of Capecitabine in pure and formulated microsphere dosage form.

Microbiological and physicochemical studies of soil near Bhokar of Maharashtra.

A field study was conducted at Bhokar for the soil and its various contents during the period of September 2010 to August 2011. A thorough survey was carried out to examine the quality of soil samples collected from agricultural farmlands around Bhokar city of Maharashtra state, India. The soil is mainly alluvial in nature. Data presentation revealed different values of physical and chemical characteristics of the soil. The objective of the study was to assess and compare the physicochemical properties of this soil. The study was carried on few selected physical, chemical and microbiological characterization and that to the quality soil and its nature. The standard analytical methods were applied for the analysis of soil under study.

Rapid analytical procedure for Citicoline in bulk and pharmaceutical dosage form by UV Spectrophotometer.

A simple, rapid, accurate, precise, and inexpensive method for the determination of citicoline has been developed using double beam UV spectrophotometer. Ultraviolet spectrophotometric analysis was carried out on a Shimadzu UV 1800 (Shimadzu, Japan) spectrophotometer, in a 1cm quartz cuvette. Citicoline has absorption maxima at 272 nm and the measurements were obtained against distilled water. Beer Lambert’s law was obeyed in the concentration range of 5-50μg/ml with correlation coefficient (r2) 0.9998. The analytical method was successfully validated in order to verify its proper selectivity, linearity, accuracy and precision for the goal intended and its further implementation for the quantification of the active compound in the pharmaceutical speciality for quality control.

New Spectrophotometric Methods for Simultaneous Determination of Amlodipine besylate and Lisinopril in Tablet Dosage Forms.

Two simple, accurate, precise, reproducible, requiring no prior separation and economical procedures for simultaneous estimation of Amlodipine besylate (AML) and Lisinopril (LIS) in tablet dosage form have been developed. First method is simultaneous equation method; in this method 360.0 nm and 248.0 nm were selected to measure the absorbance of drugs at both wavelengths. The second method is Q-value analysis based on measurement of absorptivity at 300.0 nm (as an iso-absorptive point) and 360.0 nm. AMD and LIS at maximum wavelength of AML, 360.0 nm and at isoabsorptive point 300.0 nm shows linearity in a concentration range of 5- 40 μg/mL. Recovery studies range from >99.82% for AMD and >98.09% for LIS in case of simultaneous equation method and >100% for AMD and >98.45% for LIS in case of Q-analysis method confirming the accuracy of the proposed method. The proposed methods are recommended for routine analysis since it is rapid, simple, accurate and also sensitive and specific (no heating and no organic solvent extraction is required).

Statistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend.

A new simple, rapid and reliable UV Spectrophotometry method was developed and validated for the estimation of Efavirenz in blend & Tablets formulations. The method was based on simple UV estimation in cost effective manner for regular laboratory analysis. The instrument used was Perkin Elmer, UV Spectrophotometer (Lambda 25) and using 0.1 N NaoH as solvent system. Sample were analysed using UV Win Lab 5.2.0 Software and matched quartz cells 1 cm and was monitored at 302 nm. Linearity was obtained in the concentration range of 2 - 10 mg mL–1 for Efavirenz. The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. Spectrophotometric interferences from the Tablets excipients were not found. The results of blend uniformity and content uniformity, done on process validation batches samples.