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A New Stability-indicating Chiral RP-HPLC Method for the Determination of Degradation Products in Meclizine Hydrochloride

Author(s):

Bryan Gowramma*, Ramachandran Senthil Kumar, Kaviarasan Lakshmanan, Rajagopal Kalirajan and Subramanian Nainar Meyyanathan   Pages 1 - 13 ( 13 )

Abstract:


Background: An enantiomeric separation of stability-indicating high-performance liquid chromatographic method was developed and validated for the analysis of Meclizine enantiomers. The degradation behaviour of Meclizine Hydrochloride was investigated under different stress conditions recommended by International Conference on Harmonization (ICH).

Experiment: Enantiomeric resolution of the drug and complete separation from its degradation products were successfully achieved on a Phenomenex® lux cellulose 1 C18 (250 mm × 4.6 mm i.d, 5 µm particle size) column, using UV detector at a wavelength of 230 nm, with mobile phase consisting of acetonitrile, 20mM ammonium bicarbonate at the ratio of 75:25 (v/v), and a flow rate of 1 mL/min. The drug was subjected to alkaline, acidic, neutral, oxidative and photolytic conditions in order to mimic stress conditions.

Result: The degradation products were well resolved from main peak and proving the stability-indicating power of the method. The developed method provided linear responses within the concentration range 1-5 µg/mL, and regression analysis showed a correlation coefficient value (r2) of 0.999. The HPLC method was validated as per ICH guidelines with respect to specificity, precision, linearity and robustness. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.25 µg/mL and 1.00 µg/mL respectively.

Conclusion: The method provides good sensitivity and excellent precision and reproducibility. The method was highly selective, where degradation products and co formulated compounds did not interfere. The proposed method was successfully applied in pharmaceutical preparations.

Keywords:

Meclizine Hydrochloride, Enantiomers, Chirality, RP-HPLC, ICH, Validation, Chiral, RP-HPLC, Stabilityindicating method

Affiliation:

Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Udhagamandalam, Nilgiris-643001, Tamilnadu



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