Current Issue : January-March Volume : 2012 Issue Number : 1 Articles : 4 Articles
Dapoxetine HCl, a selective serotonin reuptake inhibitor is a novel drug for premature ejaculation and no dissolution study for its estimation has been reported yet. The aim of this work was to develop and validate a dissolution profile for Dapoxetine HCl in a tablet dosage form using spectrophotometric method. The conditions established for dissolution were: 900 mL of 0.1 N HCl as dissolution medium, using a paddle type dissolution apparatus at a stirring rate of 100 rpm which was able to give % drug release of 96.2666 . The drug release was evaluated by UV spectrophotometric method at 291 nm and a good linearity was observed in the concentration range of 1-6 �µg/mL with correlation coefficient-0.998. The percentage recovery of Dapoxetine HCl was found to be 97.88 �±0.2338 and % CV (0.5713; n=6) indicated a good precision of the analytical method. The limit of detection (LOD) and limit of quantitation (LOQ) were 0.0291 �µg/mL and 0.0882 �µg/mL, respectively. Robustness of the method was performed by using different rotation speeds and doses of the drug. The validation parameters included linearity, accuracy, precision, LOD, LOQ and robustness. The comparison study was performed between dissolution profiles of three different doses of Dapoxetine HCl tablets (30 mg, 60 mg and 90 mg) and the results were recorded. Analytical method validation was found to be within the acceptance criteria of the guidelines of ICH Q2 R1, FDA and FIP. The proposed method can be applied for routine quality control analysis of Dapoxetin HCl....
A new, simple and sensitive spectrophotometric method in ultraviolet region has been developed for the determination of rosuvastatin calcium and aspirin in bulk and in pharmaceutical formulations. The drug obeyed the Beer’s law [for rosuvastatin concentration range 2-22μg/ml and for aspirin concentration range2- 22μg/ml] and showed good correlation. 0.1N NaOH was used as a solvent. Sampling wavelength was 244nm for rosuvastatin calcium and 297nm for aspirin. The result of analysis was validated by recovery studies. The method was found to be simple, accurate, precise, economical and robust. In this method, there is no interference from any common pharmaceutical additives and diluents....
A reverse phase high performance liquid chromatographic method (RP-HPLC) has been developed for the simultaneous estimation of Paracetamol (PARA), Aceclofenac (ACE) and Tizanidine (TIZ) in the pharmaceutical formulation using RP-C18 (250 mm x 4.6 mm, 5 μm) column used as stationary phase. The mobile phase (Acetonitrile, Methanol and Orthophosphoric acid pH.3.5 in HPLC grade water) was pumped at a flow rate of 1.3 ml/min in the ratio of 50:40:10 and the eluents were monitored at 260.0 nm. Linearity was obtained in the concentration range of 100-1500μg/ml for PARA, 1-500μg/ml ACE and Tizanidine hydrochloride having range of 1-20 μg/ml. The method was statistically validated and RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. Due to its simplicity, rapidness, high precision and accuracy, the proposed RP-HPLC method may be used for determining Paracetamol, Aceclofenac and Tizanidine in bulk drug samples....
A simple, precise, accurate UV Spectroscopic method has been developed for estimation of capecitabine in pure and pharmaceutical dosage form. UV -spectroscopic method which is based on measurement of absorption of UV light, the spectra of capecitabine in glass distilled water showed maximum wavelength at 302 nm and calibration graphs were plotted over the concentrations ranging from 10-60 �µg/ml-1 of capecitabine with correlation coefficient 0.9996. Validation was performed as per ICH Q2 (R1) guidelines for linearity, accuracy, precision and recovery. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.16 and0.456 respectively by simple UV spectroscopy....
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