Abstract

STABILITY INDICATING RP-HPLC METHOD FOR THE QUANTITATIVE ESTIMATION OF IMIDOCARB DIPROPIONATE IN INJECTION DOSAGE FORM

Sayali Patil*, Swati Parikh, Vijaya Kumar Munipalli, Raman Mohan Singh, Smita Nayak, Bhaskar Vaidhun

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Abstract

Objective: The primary aim of this study was a develop of simple, fast, isocratic and stability indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for quantitative estimation of Imidocarb dipropionate (IMD) in its injection dosage form. Method: The chromatographic separation was achieved on Hemochrome/C18 column (250mm × 4.6mm, 5μm particle size) by using simple mobile phase containing 0.2 % Trifluroacetic acid (TFA): Acetonitrile (ACN) in the ratio of 80: 20 % (v/v). Diluent used was water and ACN in the ratio of 1: 1% v/v. The flow rate used was 1.0 ml/min and detection was carried out at 243 nm. Result: The Retention time for method was about 6.08 min. The reliability and analytical performance of proposed HPLC method was statistically validated with respect to linearity, ranges, precision, accuracy, robustness, detection and quantification limits. The method was linear in the range of 5-40 μg/ml, with correlation coefficient 0.9999. The limit of detection and limit of quantification was found to be 0.0015 and 0.0048 μg/ml, respectively. The forced degradation studies were performed by exposing drug to various conditions like acid, alkaline, thermal, water, oxidation and photolytic degradation conditions. The obtained results shows that the method is specific and no interferences due to excipients as well as degradation products and can be used for routine quality control of IMD in injection dosage form. Conclusion: The HPLC method developed for quantitative estimation of IMD was successfully evaluated with respect to linearity, precision, accuracy, robustness, limit of detection and limit of quantification. The validated HPLC method can be applied for determination of IMD in injection dosage form.

Keywords: Force degradation studies, IMD, Method development, RP-HPLC, Stability-indicating determination.