Author/Authors :
Topalli، Srinivasu نويسنده Ranbaxy Research Laboratories Ltd., R&D-1, Plot No.20, Sector18, Udyog vihar industrial area, Gurgaon-122001, Haryana, India , , BN، Rao نويسنده Flat No: 502, Sankalp Paradise, Visakhapatnam, A.P, India. , , Annapurna، Mathrusri نويسنده GITAM Institute of Pharmacy, GITAM University, Rushikonda, Visakhapatnam – 530045, Andhra Pradesh, India. , , Sharma، Ashutosh نويسنده , , T.G، Chandrashekhar نويسنده Ranbaxy Research Laboratories Ltd., R&D-1, Plot No.20, Sector18, Udyog vihar industrial area, Gurgaon-122001, Haryana, India ,
Abstract :
A simple, sensitive and rapid reversed-phased high performance liquid chromatographic method has been developed for the separation and quantitative determination of the related substances of Clarithromycin in Clarithromycin powder for an oral suspension dosage form. The chromatographic separation was achieved on a reversed phase Purospher Star RP18 (150 x 4.6 mm, particle size 3.0µm) column with guard column of KR100-5C1810C. A mixture of acetonitrile-0.035mol L-1 potassium dihydrogen orthophosphate at PH 4.4 was used as the mobile phase, eluent flow rate monitored at 0.8 mL-1 and the UV detection at 210 nm. In forced degradation studies, the effect of acid, base, oxidation, UV light and temperature were investigated, showing good resolution between the peaks corresponds to process related impurities and degradation products from the analyte were achieved. Significant degradation was observed during oxidative stress and the degradation product formed was identified by Liquid Chromatography Mass Spectrometry (LC-MS/MS). The proposed method was validated in terms of linearity, accuracy, precision, ruggedness and robustness. This method found to simple, rapid, specific and reliable for the determination of related substances of Clarithromycin in Clarithromycin powder for oral suspension. The method was fully validated and results from validation confirm that the method is highly suitable for its intended purpose.
