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Abstract
Development and Validation of Ultra Performance Liquid Chromatographic Method for the Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, Doravirine and Efavirenz in Bulk and Pharmaceutical Formulations
Author(s): PRASANTHI CHENGALVA* AND MADHAVI KUCHANA1
Department of Pharmaceutical Analysis, Annamacharya College of Pharmacy, Rajampet 516126, 1Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), Tirupati 517502, India
Correspondence Address:
PRASANTHI CHENGALVA, Department of Pharmaceutical Analysis, Annamacharya College of Pharmacy, Rajampet 516126, India, Email: prashanthi.chengalva87@gmail.com
A simple and rapid stability indicating reverse phase ultra-performance liquid chromatographic method has been established and validated for the simultaneous quantification of lamivudine, tenofovir disoproxil fumarate, doravirine and efavirenz in bulk and pharmaceutical formulations. The chromatographic separation was performed on Acquity Ethylene Bridged Hybrid Phenyl (50 mm×2.1 mm, 1.7 μm) column. The isocratic elution system of water and acetonitrile in the ratio 50:50 v/v pumped at a flow rate 0.4 ml/min in isocratic mode. The injection volume set was 1 μl and the detection wavelength was 238 nm. The column temperature was set at 30º. The retention times of lamivudine, tenofovir disoproxil fumarate, doravirine and efavirenz were found to be 1.012 min, 1.233 min, 1.428 min and 1.666 min respectively with a total run time of 3 min. The proposed method was validated according to International Council on Harmonisation Q2 (R1) guidelines. The percentage recoveries were found to be in the range of 99.56 -100.40 %. The relative standard deviation values obtained during precision studies were found to be less than 2. Linearity between concentration and response was found within the specified concentration range and the correlation coefficient was found to be 0.999 for all the drugs. Degradation studies were carried out under various stress conditions such as acid, base, oxidation, heat and light and found no interference of degraded impurity peaks at the retention time of analyte peaks. Hence, the proposed ultra-performance liquid chromatographic method can be utilized in the routine quality investigation of lamivudine, tenofovir disoproxil fumarate, doravirine and efavirenz either individually or simultaneously in bulk and co-formulated dosage forms.
Department of Pharmaceutical Analysis, Annamacharya College of Pharmacy, Rajampet 516126, 1Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), Tirupati 517502, India
Correspondence Address:
PRASANTHI CHENGALVA, Department of Pharmaceutical Analysis, Annamacharya College of Pharmacy, Rajampet 516126, India, Email: prashanthi.chengalva87@gmail.com
A simple and rapid stability indicating reverse phase ultra-performance liquid chromatographic method has been established and validated for the simultaneous quantification of lamivudine, tenofovir disoproxil fumarate, doravirine and efavirenz in bulk and pharmaceutical formulations. The chromatographic separation was performed on Acquity Ethylene Bridged Hybrid Phenyl (50 mm×2.1 mm, 1.7 μm) column. The isocratic elution system of water and acetonitrile in the ratio 50:50 v/v pumped at a flow rate 0.4 ml/min in isocratic mode. The injection volume set was 1 μl and the detection wavelength was 238 nm. The column temperature was set at 30º. The retention times of lamivudine, tenofovir disoproxil fumarate, doravirine and efavirenz were found to be 1.012 min, 1.233 min, 1.428 min and 1.666 min respectively with a total run time of 3 min. The proposed method was validated according to International Council on Harmonisation Q2 (R1) guidelines. The percentage recoveries were found to be in the range of 99.56 -100.40 %. The relative standard deviation values obtained during precision studies were found to be less than 2. Linearity between concentration and response was found within the specified concentration range and the correlation coefficient was found to be 0.999 for all the drugs. Degradation studies were carried out under various stress conditions such as acid, base, oxidation, heat and light and found no interference of degraded impurity peaks at the retention time of analyte peaks. Hence, the proposed ultra-performance liquid chromatographic method can be utilized in the routine quality investigation of lamivudine, tenofovir disoproxil fumarate, doravirine and efavirenz either individually or simultaneously in bulk and co-formulated dosage forms.
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