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Ravichandra Babu, R.
- Stability Indicating HPLC Method Development and Validation for Thalidomide and its Impurity Determination
Abstract Views :178 |
PDF Views:2
Authors
Affiliations
1 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, IN
2 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, GL
1 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, IN
2 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, GL
Source
Asian Journal of Pharmaceutical Analysis, Vol 6, No 2 (2016), Pagination: 115-118Abstract
A simple, accurate, precise, stability indicating HPLC method was carried for the determination of thalidomide along with its impurities. An HPLC isocratic separation was achieved on Develosil ODS UG-5 column (150mm X 4.6 mm X 5um particle size) with a mobile phase 0.01M potassium dihydrogen orthophosphate and Acetonitrile in the ratio of 80:20 (v/v) 1.02gm in 500 ml. The flow rate was set at 0.700ml with a detection wavelength of 297nm. The linearity range of thalidomide and its impurities were 0.99914, 0.99966 and 0.99968 respectively. The drug undergoes degradation under acid, base, H2O2, thermal and humidity conditions. The method was validated for precision, accuracy, ruggedness and robustness as per ICH guidelines.Keywords
Thalidomide, HPLC, Stability Indicating, Method Validation.
- Method Development and Validation of Valsartan and Its Impurities by High Performance Liquid Chromatography
Abstract Views :253 |
PDF Views:5
Authors
Affiliations
1 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, 530045, IN
1 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, 530045, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 2 (2017), Pagination: 87-92Abstract
Our main objective is to develop an accurate and precise HPLC method for the determination of valsartan and its impurities. An inertsil ODS-3v; (150 × 4.6) mm; 5 μm column is used for the Separation of drugs. The flow rate was maintained at 1.0 mL/min and the wave length used for detection was 230 nm. The linearity was observed in the range of 0.025-50μg/ml of spiked impurities in valsartan, impurity B and impurity C with a correlation coefficient of 0.990, 0.996 and 0.997 respectively. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation. The developed method can be utilized in the analysis of valsartan tablets.Keywords
HPLC, Method Validation, Related Impurities, Entacapone, LOQ, LOD.- Stability Indicating High Performance Liquid Chromatographic Assay for the Determination of Sildenafil Tartrate
Abstract Views :171 |
PDF Views:0
Authors
Affiliations
1 Department of Chemistry, Institute of science, GITAM University, Visakhapatnam, Andhra Pradesh, IN
1 Department of Chemistry, Institute of science, GITAM University, Visakhapatnam, Andhra Pradesh, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 3 (2017), Pagination: 196-200Abstract
A simple, fast, accurate and specific reverse phase high pressure liquid chromatographic (HPLC) method has been developed for simultaneous determination of Sildenafil base and its impurities in the Sildenafil Tartrate (API). The method was developed by reversed phase chromatography equipped with C18 (100 × 4.6 nm × 5.0 nm) column using mobile phase of (0.1%) formic acid and methanol (30:70 ratio) with a flow rate of 0.5 ml/min with ultraviolet detector configured at 290nm. The method was validated as per ICH guidelines.Keywords
Sildenafil Tartrate, HPLC, Stability Indicating, Method Development, Validation.References
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