Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Simultaneous Estimation of Paracetamol, Caffeine and Carisoprodol in Tablet Formulation
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Department of Quality Assurance Technique and PG studies, M.E.S. College of Pharmacy, Sonai, Tq-Newasa, Dist.-Ahmednagar, Maharashtra, India-414105
Department of Pharmaceutical Chemistry and PG studies, M.E.S. College of Pharmacy, Sonai, Tq-Newasa, Dist.-Ahmednagar, Maharashtra, India-414105
Publish date: 2017-10-05
Eurasian J Anal Chem 2015;10(3):163–179
Combined dose tablet formulation containing Paracetamol, Caffeine and Carisoprodol is used for the treatment of low back pain, post traumatic muscle spasm, sprains, strains and tenosynovitis. In this study a simple, specific, precise and accurate reverse phase high performance liquid chromatographic (RP-HPLC) methods has been developed for simultaneous estimation of paracetamol (PAR), caffeine (CAF) and carisoprodol (CAR) in tablet dosage form. In the proposed chromatographic method separation was achieved by HiQ silC-18HS column (250 mm× 4.6 mm), with mobile phase containing Acetonitrile: Buffer (0.1mol L-1 Orthophosphoric Acid) (30:70 v/v) and the pH of the Buffer was adjusted to 3.1 by triethylamine. The flow rate was 1.0 ml min-1 and effluent was monitored at 232.2 nm. The retention time of CAF, PAR and CAR were 2.804 min, 4.815 min and 6.718 min respectively. The linearity for PAR, CAF and CAR were in the range of 5-25 µg mL-1, 5-25 µg mL-1 and 10-50 µg mL-1 respectively. The recoveries of PAR, CAF and CAR were found in the range of 99.05-99.78 %, 98.47-99.90 % and 98.92-99.56 % respectively. The proposed methods were validated as per International Conference on Harmonisation (ICH) guidelines by means of different parameters likes linearity, precision, accuracy, and limit of detection, limit of quantitation, range and selectivity, robustness ruggedness, solution stability as per ICH guidelines and successfully applied to the estimation of PAR, CAF and CAR in the tablet dosage form.
Shantaram G. Khanage   
Department of Quality Assurance Technique and PG studies, M.E.S. College of Pharmacy, Sonai, Tq-Newasa, Dist.-Ahmednagar, Maharashtra, India-414105
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