STABILITY INDICATING RP-LC ASSAY METHOD FOR CARISOPRODOL
Keywords:Carisoprodol, Stability-Indicating HPLC Method, Stress Conditions
Objective: A reverse phase stability-indicating HPLC method was developed for the determination of Carisoprodol in pharmaceutical dosage forms. The chromatographic elution was achieved on C18, 250 mm Ã— 4.6 mm, 5-Î¼m particle size column.
Methods: The mobile phase contains a mixture of water and acetonitrile in ratio of 60:40 v/v. The flow rate was 1.0 ml min-1 and was detected by Refractive index detector.
Results: The method was proven to be linear over a range of 1 to 4 mg/ml with a mean correlation coefficient of 0.99998. The %mean recovery is in the range of 100.55% to 101.11% and %RSD was less than 1.0% between preparations. The % RSD for Assay results of initial sample preparation in different intervals of 0hr, 24 h, 30 h and 48 h was less than 1.0%. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from Carisoprodol.Conclusion: The developed method was validated as per international ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.
Miller AR. A comparative study of parafon forte tablets and soma compound in the treatment of painful skeletal muscle conditions. Curr Thera Res Clin Exp 1976;19:444-50.
Ralph L, Look M, Wheeler W, Sacks H. Double-blind, placebo-controlled trial of carisoprodol 250-mg tablets in the treatment of acute lower-back spasm. Curr Med Res Opinion 2008;24:551-8.
Berger FM, Kletzkin M, Ludwig BJ, Margolin S. The history, chemistry, and pharmacology of carisoprodol. Annals New York Academy Sci 1960;86:90-107.
Longo VG. The effect of carisoprodol on the central nervous system. Ann New York Academy Sci 1960;86:143-6.
Mohrhaus AS, Gratz SR. Identification and determination of carisoprodol in tablets by liquid chromatography/mass spectrometry. Microgram 2004;2:36.
Skinner W, McKemie D, Stanley S. Quantitative determination of carisoprodol and its metabolites in equine urine and serum by liquid chromatography-tandem mass spectrometry. Chromatographia 2004;59:S61-7.
Kucharczyk N, Segelman FH, Kelton E, Summers J, Sofia RD, Mahrous H, et al. Gas chromatographic determination of carisoprodol in human plasma. J Chromatogr B: Biomed Sci Appl 1986;377:384-90.
Kintz P, Mangin P, Lugnier AA, Chaumont AJ. A rapid and sensitive gas chromatographic analysis of meprobamate or carisoprodol in urine and plasma. J Anal Toxicol 1988;12:73-4.
Fisher J, Sherma J. Analysis of carisoprodol tablets by HPTLC with visible absorbance densitometry. Acta Chromatographica 2001;11:96-101.
Wang G, Huynh K, Barhate R, Rodrigues W, Moore C, Coulter C, et al. Validation of a new homogeneous immunoassay for the detection of carisoprodol in urine. J Anal Toxicol 2011;35:108-12.
Pure SD. Spectrophotometric determination of carisoprodol in pure and pharmaceutical forms using triphenyl methane dyes. Int J Pharm Sci Res 2015;11:90.
Rohith T, Ananda S, Gowda NM. Method development and validation of carisoprodol and its impurities by ultra violet-high performance liquid chromatography. Adv Anal Chem 2013;3:15-9.