STABILITY INDICATING CHROMATOGRAPHIC METHODS FOR THE DETERMINATION OF PHARMACEUTICAL DOSAGE FORMS CONTAINING CALCIUM DOBESILATE IN THE PRESENCE OF ITS INTERFERING SUBSTANCES
Keywords:Calcium-dobesilate, Lidocaine hydrochloride, Dexamethasone acetate, RP-HPLC, HPTLC-spectrodensitometry
Objective: Two simple, accurate and precise chromatographic methods were developed for the determination of calcium dobesilate in the presence of its interfering substances as its degradation product and/or impurity hydroquinone in pharmaceutical dosage forms with lidocaine hydrochloride alone or in combination with dexamethasone acetate.
Methods: The first method is HPTLC-spectrodensitometric one using benzene: methanol: ethyl acetate: ammonia: sodium lauryl sulphate (7: 2.1: 2.5: 0.1: 0.05 v/v/v/v/w) as a developing system and scanned at 220 nm. Second one is an HPLC method where the mixture was separated on an ODS-3 C18 column with flow rate 1 ml/min and the mobile phase was phosphate buffer: acetonitrile (35:65 v/v) (adjusted to pH 3.4 with o- phosphoric acid), scanned at 220 nm.
Results: The robustness of the method was determined to assess the effect of small but deliberate variation of the chromatographic conditions on the determination of cited drugs in a presence of interfering substances. Robustness was determined by changing the mobile phase flow rate to 0.5, 1,and 1.5 mLminâˆ’1, pH to 3.5, 4, and 5, and the concentration of acetonitrile in the mobile phase to 60% and 80%. The proposed methods were checked using laboratory-prepared mixtures and were successfully applied for the analysis of pharmaceutical formulations containing the cited drugs and were validated via ICH guidelines.
Conclusion: The proposed methods could be used for the routine analysis of the cited drugs in their pharmaceutical formulation in quality control laboratories.
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