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a n a l y t i c a l m e t h o d d e v e l o p m e n t a n d v a l i d a t i o n f o r t h e（a n a l y t i c a l t h o m e d d e v e l o p m e n t a n d v a l i d a t i o n f o r t h e）.doc

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Research Article DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF VITAMINS B1, B3, B5 AND B6 IN MULTI VITAMIN INJECTION T. Jeyalakshmi1, A. Chenthilnathan1* and A.Vairamani 2 1Department of Pharmaceutical Chemistry, Manonmaniam Sundaranar University, Tirunelveli – 627 012, Tamil Nadu, India. 2Caplin Point Laboratories Ltd., Gummidipoondi Taluk, Chennai – 601 201, Tamil Nadu, India. *Corresponding Author A. Chenthilnathan Assistant Professor Head i/c Department of Pharmaceutical Chemistry Manonmaniam Sundaranar University, Tirunelveli – 627 012, Tamil Nadu Email: ala.chenthil@ ABSTRACT A simple, efficient and reproducible RP-HPLC method for simultaneous determination of vitamins B1 (Thiamine hydrochloride), B3 (Nicotinamide), B5 (Dexpanthenol) and B6 (Pyridoxine hydrochloride) in a combined multivitamin injection dosage form has been developed and validated. The Chromatographic Separation was carried out on Water C18 (250 × 4.6mm; 5μm) column using the mobile phase consists of buffer (pH 3.5) and methanol in the ratio 95:5. The mobile phase was flowed at the rate of 1.5 ml/min and effluent was detected at 210 nm. The retention times of Thiamine hydrochloride, Nicotinamide, Dexpanthenol and Pyridoxine hydrochloride were 2.492 min, 6.748 min, 20.084 min and 4.077 min respectively. The method was validated according to ICH guidelines and the acceptance criteria for system suitability, specificity, linearity, accuracy, precision and ruggedness were met in all cases. The method was linear in the range of 10-200 μg/ml for Thiamine hydrochloride (r2 = 0.9992), 40-800 μg/ml for Nicotinamide (r2 = 0.9994) 10-200 μg/ml for Dexpanthenol (r2 = 0.9993) and 8-160 μg/ml for Pyridoxine hydrochloride (r2 = 0.9991). The percentage relative standard deviation for precision was found to be less than 2.0%. Hence, the method could be successfully applied for routine analysis of B1 (Thiamine hydro