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 Joshi^{1، 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