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Joshi, Aniket S, Warghude, Nilesh, Deshmukh, Sanjay, Jadhav, Sanjay A, Bembalkar, Saroj R. (1392). Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form. نشریه علمی پژوهشی دانشگاه آزاد اسلامی, 4(1), 241-249. doi: https://doi.org/10.1186/2228-5547-4-32
Aniket S Joshi; Nilesh Warghude; Sanjay Deshmukh; Sanjay A Jadhav; Saroj R Bembalkar. "Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form". نشریه علمی پژوهشی دانشگاه آزاد اسلامی, 4, 1, 1392, 241-249. doi: https://doi.org/10.1186/2228-5547-4-32
Joshi, Aniket S, Warghude, Nilesh, Deshmukh, Sanjay, Jadhav, Sanjay A, Bembalkar, Saroj R. (1392). 'Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form', نشریه علمی پژوهشی دانشگاه آزاد اسلامی, 4(1), pp. 241-249. doi: https://doi.org/10.1186/2228-5547-4-32
Joshi, Aniket S, Warghude, Nilesh, Deshmukh, Sanjay, Jadhav, Sanjay A, Bembalkar, Saroj R. Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form. نشریه علمی پژوهشی دانشگاه آزاد اسلامی, 1392; 4(1): 241-249. doi: https://doi.org/10.1186/2228-5547-4-32

Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form

International Journal of Industrial Chemistry
دوره 4، شماره 1، اسفند 2013، صفحه 241-249
نوع مقاله: research article
شناسه دیجیتال (DOI): https://doi.org/10.1186/2228-5547-4-32
نویسندگان
Aniket S Joshi1، 2؛ Nilesh Warghude1؛ Sanjay Deshmukh1؛ Sanjay A Jadhav2؛ Saroj R Bembalkar* 2
1Research and Development, Emcure Pharmaceuticals Ltd, Pimpri, Pune, 411018, India
2Department of Chemistry, Deogiri College, Aurangabad, 431004, India
چکیده
Background
A simple and rapid stability-indicating, reversed phase ultra-performance liquid chromatography (UPLC) method was developed for the quantitative determination of lafutidine and its four potential impurities.
Results
Separation was achieved on Acquity BEH-shield RP18 UPLC column (3.0 mm × 100 mm, 1.7 μm) under the gradient mode of elution by using mobile phase A (0.02M diammonium hydrogen phosphate/acetonitrile, 80:20 v/v) and mobile phase B (0.02M diammonium hydrogen phosphate/acetonitrile, 30:70 v/v). The flow rate was maintained at 0.5 mL min−1. UV detection was carried out at 276 nm.
Conclusions
Stability-indicating capability of the developed method is established by analyzing forced degradation samples in which the spectral purity of lafutidine is ascertained along with the separation of degradation products from analyte peak. The developed UPLC method is validated as per International Conference on Harmonization guidelines with respect to system suitability, specificity, precision, sensitivity, accuracy, linearity, and robustness.
کلیدواژه‌ها
Lafutidine؛ UPLC؛ Degradation؛ RSD and validation؛ Stability indicating
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تعداد مشاهده مقاله: 13


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