The aim of present work is formulation and evaluation of Lamivudine from sustained release matrix tablet by using Kollidon SR as a release retarding agent.Sustained release matrix tabletof Lamivudine were prepared by direct compression method using Kollidon SR as a release retardant. Dicalcium phosphate is used as diluent in different concentration. Compatibility study was carried out by FT-IR. The powder were evaluated for their flow properties and tablet were evaluated for hardness, friability, thickness, % weight variation, % drug content and in-vitro dissolution test. In result it was found that the formulation containing 300mg of Kollidon SR sustained the drug release.
N. A. Pragathi*, S. Parthiban, A. Vikneswari, G. P. Senthil kumar, T. Tamizmani.
The aim of the present study was an attempt to formulate and evaluate taste masked fast disintegrating tablets of Captopril to increase the palatability and bioavailability of the drug. Fast disintegrating tablets of Captopril were prepared by direct compression method using β-cyclodextrin as a complexing agent to mask the bitter taste of Captopril. Psyllium husk as natural superdisintegrants was used in different concentration 2.5 mg, 5 mg, 7.5 mg, 10 mg respectively. The Captopril - β-cyclodextrin complex were characterized by FT-IR, DSC and XRD. Compatibility studies by FT-IR showed no significant interactions between drug and excipients. DSC and XRD analysis confirmed the formation of complex for taste masking. The developed tablet formulations were evaluated for pre compression and post compression parameters which complied official limits. Among all the formulations, formulation F4 containing psyllium husk 10 mg gives best disintegration and dissolution profile compared with other formulations. The formulation F4 showed drug release of 99.84±0.18 % with very less time (4 min) and disintegration time 41.33±1.21 (sec). From this study we concluded that the formulated tablets of Captopril containing psyllium husk of concentration 10 mg was better and effective than conventional tablets to meet patient compliance along with fast relief from hypertension.
Sunitha H S*, S Parthiban, A Vikneswari, G P Senthil kumar, T Tamiz Mani.
A simple, fast, accurate and precise UV-spectroscopic method and RP-HPLC method were developed and validated for the estimation of Imatinib/Capecitabine per ICH guidelines. Acetonitrile and water (50:50) was used as the solvent. The λ max of Imatinib/Capecitabine was found to be 242 nm and it was proved linear in the concentration range of Imatinib 0.5-3μg/ml and for Capecitabine 1-6μg/ml with a correlation coefficient value of 0.999. Accuracy studies of UV-spectroscopy method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 99.6 to 100.8% for Imatinib and the range of 98.3 to 101.2% for Capecitabine respectively. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 0.217 and 0.658 µg/ml for Imatinib and 0.103 and 0.312 for Capecitabine. RP-HPLC method was developed by using Acetonitrile: water, 0.1% ortho phosphoric acid (50:50). The method was developed in Eclipse C18 column (100 mm × 4.6 mm, 3.5μm particle size). In RP-HPLC method was found to be linear in the range of Imatinib/Capecitabine is 0.25-1.5µg/ml with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 98.24 to 100.3% for Imatinib and the range of 98.18 to 99.98% and for Capecitabine respectively. The limit of detection (LOD) and Limit of Quantification (LOQ) were found to be 0.0421 and 0.1276 µg/ml for Imatinib and 0.047.and0.1424 µg/ml for Capecitabine for RP-HPLC method. The % RSD is <2% which indicates the accuracy and precision of the method. The above method was a rapid tool for routine analysis of Imatinib/Capecitabine in the bulk and in the pharmaceutical dosage form.
Alagar Raja. M*, Anusha. S, David Banji, Rao. K. N.V, Selva Kuamar. D.
A simple, accurate, precise, sensitive, rapid UPLC method has been developed and validated for determination of citicolin sodium and piracetam in its pharmaceutical dosage form. Chromatographic separation was achieved on a beh shield rp18 (2.1 x 100mm, 1.7µm), by a mobile phase consist of Water: Acetonitrile (pH 2.8, 45:55 v/v). Ratio with a flow rate of 0.3 ml /min. The detection wave length was set at 225 nm. Citicolin and piracetam was subjected to different stress conditions. The degradation products, when any, were well resolved from the pure drug with significantly different retention time values. The method was linear (r2 = 0.999) at a concentration range of 5-25 μg/ml. The intra and inter day precisions were satisfactory the relative standard deviations did not exceed 2%. The accuracy of the method was proved the mean recovery of citicolin sodium and piracetam was 99.04-101.58%. The proposed method has high throughput as the analysis involved short run-time (3mins). The method met the ICH/FDA regulatory requirements. The proposed method was successfully applied for the determination of citicolin sodium and piracetam with acceptable accuracy and precisions. The results demonstrated that the methodcan be applied successfully for routine use in quality control industry laboratories.
Alagar Raja. M*, B. Rajani, David Banji, K.N.V. Rao, Selva Kumar. D.
A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Metformin HCl (MET) and Pioglitazone (PIO) in pure and in pharmaceutical dosage forms. A ODS HG-5 RP C18 column (150x4.6mm,i.d 5mm) was used with a mobile phase containing a mixture of Acetonitrile and Potassium dihydrogen phosphate buffer (pH-3) in the ratio of (80:20.V/V). The flow rate was 1ml/min and effluents were monitored at 242nm and eluted at 1.93min (MET) and 5.29min (PIO). Calibration curve was plotted with a range from 0-750 µ g / ml for (MET) and 0-25 µ g / ml for PIO. The assay was validated for the parameters like accuracy, precision, specificity, robustness, ruggedness and system suitability parameters. The proposed method can be useful in the routine analysis for the determination on metformin and pioglitazone in pharmaceutical dosage forms.
M. Alagar raja*, CH. Usha Rani, David banji, K. N. V. Rao, D. Selva Kumar.