STABILITY-INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF LACIDIPINE IN TABLETS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 5
Abstract
A stability-indicating HPLC method development and validation for the determination of Lacidipine in tablets. The determination was done for an active pharmaceutical ingredient, its pharmaceutical dosage form in the presence of degradation products impurities. The drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation as per International Conference on Harmonization (ICH) prescribed stress conditions to show the stability-indicating method. Degradation was observed during acid, base hydrolysis, thermal, peroxide and light stressed sample and degradant was identified by LC–MS, FTIR and 1H/13C NMR spectral analysis. The generated samples were used for forced degradation studies. In the developed HPLC method, the resolution between Lacidipine and, its related impurities (namely impurity-A, impurity-B, impurity-C, impurity-LC1 and impurity-LC2) was found. The chromatographic separation was achieved on a phenomenex Luna C18, 250 mm × 4.6 mm, 5 µm column. The LC method employed an isocratic elution, and the detection wavelength was set at 240 nm. The stress samples were assayed against a qualified reference standard and the mass balance was found to be close to 99.6 %. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.
Authors and Affiliations
Rajavel A , priya Sanmuga , selvan Senthamil , Rajagopal K , Mallikarjuna Rao Durga
Keywords
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