Résumé
A method for simultaneous estimation of Atorvastatin Calcium (AVS) and Amlodipine Besilate (AML) in combined tablet dosage form has been developed. The method employs the application of multicomponent mode of analysis. This method utilize Phosphate buffer (pH6.8). AVS show maximum absorbance at a wavelength of 240 nm and AML at 369 nm. The method is fast,economical and very cheap as compared to other simultaneous spectrophotometric method using multi-component mode of analysis for estimation of Atorvastatin Calcium and Amlodipine Besilate due to using phosphate buffer instead of costly solvent.Where the linearity ranges for AVS and AML were 5-25μg/ml and 10-50 μg/ml respectively. The procedure was successfully applied for the simultaneous determination of both drugs in laboratory prepared mixture and in market available tablet dosage form. The accuracy of the method was assessed by recovery studies and was found to be 99.41±0.83 and 98.65±0.54 for AVS and AML respectively. Results of the analysis were validated statistically so that it can be used for routine analysis of AVS and AML in combined tablet dosage form.
Résumé
A RP HPLC method for estimation of sildenafil citrate (SC) in tablet dosage form and seminal fluid was developed and validated. Best resolution was obtained with column Waters Spherisorb® C18 bonded silica, (5 μm, 4.6 x 250 mm) at 230 nm with retention time of 5.01 min. The mobile phase used was TEA (0.2%) pH adjusted at 3 with OPA and ACN (60:40) with flow rate of 1.0 mL/min. The method for estimation of sildenafil citrate in tablet dosage form was found to be linear, accurate, precise, sensitive and selective. Whereas the bioanalytical estimation of SC in seminal fluid was found to be in the range of 100 ng/mL to 10μg/mL. Method was found to be highly sensitive as LOD and LOQ were found to 0.3 μg/ml and 0.9μg/ml. The repeatability and reproducibility were within the range i.e. less than 2%.The accuracy of the method was 99.3%. The percentage purity was calculated for market formulation was 102.8%. The internal standard used for bioanalytical methods was Diclofenac sodium. The drug was extracted from seminal fluid by protein precipitation using ACN as precipitating agent. The linearity range was from 100.0ng/mL to 2.0μg/mL. The LOD and LOQ were found to 0.03μg/mL and 0.1μg/mL. The repeatability and reproducibility were within the range i.e. % RSD less than 15%. The accuracy of the method was 90.36%.and the extraction efficiency was found to be 98.25%. The stability of drug was found to be within the range i.e. less the 15%.
Résumé
The aim of the present work was to develop simple, shorter and effective HPLC method with UV detection (285nm) and subsequent validation for the content uniformity determination of Rabeprazole Sodium in marketed tablet samples. The method uses isocratic mobile phase of 0.1M sodium phosphate buffer (pH adjusted to 6.5 with sodium hydroxide solution) and acetonitrile 65:35 compositions on reverse phase Lichrosphere RP-100 C8 column. The RSD was observed to 0.21 percentage and linearity range of (LOQ) 0.025 – 150 percentage of label claim established with 0.9999 correlation, 8 different brands marketed samples were successfully analysed for content uniformity and compared the results with the USP and other guidelines for acceptance criteria. The developed method was found precise, linear, rugged and robust for validated parameters. The method can be used for assay and the content uniformity determination of Rabeprazole Sodium in its tablet dosage form.
Résumé
A simple, selective, accurate reverse phase-high Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the analysis of Sildenafil Citrate in pharmaceutical formulations. Chromatographic separation achieved isocratically on a C18 column [Use Inertsil C18, 5m , 150 mm x 4.6 mm] utilizing a mobile phase of acetonitrile/phosphate buffer (70:30, v/v, pH 7.0) at a flow rate of 0.8 ml/m with UV detection at 228 nm. The retention time was 4.087. The method is accurate (99.15-101.85%), precise (intraday variation 0.13-1.56% and inter-day variation 0.30-1.60%) and linear within range 0.1- 30μg/ml (R2=0.999) concentration and was successfully used in monitoring left over drug. The detection limit of sildenafil citrate at a signal-to-noise ratio of 3 was 1.70ng/ml in formulations while quantification limit in drug was 5.40 ng/ml. The proposed method is applicable to stability studies and routine analysis of sildenafil citrate in pharmaceutical formulations.