STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LOFEPRAMINE HYDROCHLORIDE USING HPLC
Jitendra Kumar, Munesh Singh Bhadouria, Narottam Singh, Murari Lal, Avinash Krishnarao Kondalkar
ABSTRACT
This study aimed to develop a reliable and reproducible analytical method for the quality control of Lofepramine hydrochloride by evaluating its physicochemical properties, analytical behavior, and stability. The solubility study indicated that Lofepramine hydrochloride is slightly soluble in water, ethanol, and 0.1 N HCl, but freely soluble in methanol and soluble in 0.1 N NaOH, which is critical for its dissolution and formulation strategies. A chromatographic method using a 50:50 mixture of acetonitrile and methanol at a flow rate of 1.0 mL/min was optimized, yielding well-resolved peaks and meeting system suitability parameters. Linearity studies showed a strong linear response (2 to 10 ?g/mL) with excellent precision and accuracy. Recovery studies at 80%, 100%, and 120% levels demonstrated consistent results, confirming the method’s accuracy. The method exhibited high precision, both intra-day and inter-day, with low % RSD values. The robustness study indicated the method’s resilience to variations in temperature, flow rate, and mobile phase ratio, ensuring its reliability for routine quality control. Forced degradation studies revealed that Lofepramine hydrochloride is most stable under acidic conditions, with the highest degradation occurring under oxidative and photolytic stress. In conclusion, the developed analytical method for Lofepramine hydrochloride is accurate, precise, robust, and suitable for quality control and stability testing of pharmaceutical formulations, ensuring the consistency and efficacy of the drug product.
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