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-spectrodensitometryAbstract
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 mLmin−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.
Downloads
References
Williams DA, Lemke TL. Foye's Principles of Medicinal Chemistry; 2002. p. 4222-39.
Scharm MT, Stam F, Jongh RT, Vries G, Van Dijk RAJ M, Serne E, et al. The effect of calcium dobesilate on vascular endothelial function, blood pressure, and markers of oxidation in obese male smokers: a placebo-controlled randomised clinical trial. Atheroscler 2003;170:59-72.
Brunet J, Farine JC, Garay RP, Hannaert P. Angioprotective action of calcium dobesilate against reactive oxygen species-induced capillary permeability in the rat. J Pharmacol 1998;358:213-20.
The United States Pharmacopoeia, U. The National Formulary, 25th edition. United States Pharmacopeial Convention, Rockville, MD; 2007.
British Pharmacopoeia,†The Stationery Office on Be-half of the Medicines and Healthcare Products Regulatory Agency (MHRA)-© Crown Copyright; 2013.
Song JF, Chen JQ. Flow-injection bi-amperometric direct determination of calcium dobesilate in irreversible couple system. J Pharm Biomed Anal 2003;33:789-96.
Rona K, Ary K. Determination of calcium dobesilate in human plasma using ion-pairing extraction and high-performance liquid chromatography. J Chromatography B 2001;755:245-51.
Sayed WN, Hegazy MA, Abd-el Aleem EA, M Abdelkawy, Abdelfattah RM. Stability spectrophotometric and spectrodensitomethods for determaination of calcium dobesilate in the presence of its impurity and/or degradation product. Int J Pharm Pharm Sci 2013;5:975-1491.
Gebauer MG, McClure AF, Vlahakis TL. Stability indicating HPLC method for the estimation of oxycodone and lidocaine in rectal gel. Int J Pharm 2001;223:49-54.
Kang L, Jun HW, McCall JW. HPLC assay of Lidocaine in plasma with solid phase extraction and UV detection. J Pharm Biomed Anal 1999;19(5):737-45.
Klein J, Ferandes K, Gazarian M, Kent G, Koren G. Simultaneous determination of lidocaine, prilocaine and the prilocaine metabolite o-toluidine in plasma by high-performance liquid chromatography. J Chromatography B 1994;655:83-8.
Dal Bo L, Mazzuchelli P, Marzo A. Highly sensitive bioassay of lidocaine in human plasma by high-performance liquid chromatography-tandem mass spectrometry. Journal of Chromatogr A 1999;854:3-11.
Garcia CV, Breier M, Steppe M, Schapoval ES, Oppe TP. Determination of dexamethasone acetate in cream by HPLC. J Pharm Biomed Anal 2003;31:597-600.
Collado MS, Robelles JC, De Zan M, Camara MS, Mantovani MV, HC Goicoechea. Determination of dexamethasone and two excipients (creatinine and propylparaben) in injections by using UV-spectroscopy and multivariate calibrations. Int J Pharm 2001;229:205-11.
Grippa E, Santini L, Castellano G, Gatto MT, Leone MG, Saaao L. Simultaneous determination of hydrocortisone, dexamethasone, indomethacin, phenylbutazone and oxyphenbutazone in equine serum by high-performance liquid chromatography. J Chromatogr B 2000;738:17-25.
Nepote A, Vera-Condiotti L, Williner MR, Damian PCi, Olivieri AC. Analytical Chemistry Acta 2003;487:p. 77.
Baeyens V, Varesio E, Veuthey E, Gurny R. Determination of dexamethasone in tears by capillary electrophoresis. J Chromatogr B Biomed Sci 1997;692:222-6.
Zivanovic LJ, Zecevic M, Markovic S, Petrovic S. Validation of liquid chromatographic method for analysis of lidocaine hydrochloride, dexamethasone acetate, calcium dobesilate, buthylhydroxyanisol and degradation product hydroquinone in suppositories and ointment. J Chromatogr A 2005;1088:182-6.
Lotfy HM, Tawakkol SM, Fahmy NM, Shehata MA. Validated stability indicating spectrophotometric methods for the determination of lidocaine hydrochloride, calcium dobesilate,and dexamethasone acetate in their pharmaceutical dosage forms. Anal Chem Lett 2013;3(3):208-25.
Lotfy HM, Tawakkol SM, Fahmy NM, Shehata MA. Successive UV-Spectroscopic Resolution as a novel technique for the Analysis of Ternary Mixtures of Pharmaceuticals. Spectrochim Acta Part A 2014;121:313-23.
Reema K. , Itishree V., Shantaram N. and Jagdish G., Method development and validation for the simultaneous estimation of b-group vitamins and atorvastatin in pharmaceutical solid dosage form by RP-HPLC, International Journal Of Pharmaceutical, Chemical And Biological Sciences, 2013, 3(2): 330-335.
Godse VP, Deodhar MN, Bhosale AV, Sonawane RA, Sakpal PS, Borkar DD and Bafana YS, Reverse Phase HPLC Method for Determination of Aceclofenac and Paracetamol in Tablet Dosage Form, Asian Journal of Research in Chemistry, 2009; 2(1), 37.
ICH Q2B Note for guidance on validation of analytical methods methodology. International Conference on Harmonization, IFPMA, Geneva; 1997.