Formulation and In-vitro Evaluation of Tolterodine Tartrate Tablets by Using High Performance Liquid Chromatographic (HPLC)
Keywords:Tolterodine tartrate, HPLC, Assay, Dissolution
Tolterodine tartrate, is a new, potent and competitive muscarinic receptor antagonist in clinical development for the treatment of urge incontinence and other symptoms of unstable bladder. The purpose of this study is to formulation and invitro evaluation of Tolterodine tartrate by high performance liquid chromatography with ultraviolet detection (HPLC-UV). A simple, rapid, and sensitive high-performance liquid chromatographic method was developed and evaluated for invitro formulation of Tolterodine tartrate Tablets. Tablets were analysed by measuring different parameters: lubricated granules content of Tolterodine tartrate having bulk density, tap densities and angle of r
content uniformity, assay and related substances. Separation of Tolterodine tartrate was achieved within a single chromatographic run on 5µm 4.6x250mm with UV detection at 280 nm, under isocratic conditions, using Acetonitrile and A mixture of 65 volumes of buffer solution prepared by mixing 2.2 ml of orthophosphoric acid to 1000 ml with water, adjusted to pH 3.0 with triethylamine in 35:65 ratio with a flow rate of 1.5 ml/min. From the results, it was clear that designed formulations among f7 displayed drug release in the range of 55.66% to 102.067% in 10 min, which showed improved invitro dissolution rate compared to other formulations as well as others parameters were found to be good as compared to other formulations. Similarly, the average content of formulation f7 was found to be 104.58% and Related substances should comply the test. Assays of f7 were found to be 96.04%, the limit is 90% - 110% of the label claim having weight variation range from 82.50 mg-91.50 mg.
epose And flim coated Tolterodine tartrate tablets having friability, thickness, hardness, weight variation, invitro dissolution,
. Wefer J, Truss MC, Jonas U. Tolterodine: an overview. World J Urol 2001;19:312-18.
. Hills CJ, Winter SA, Balfour JA. Tolterodine. Drugs 1998;55:813-20.
. Palmer L, Anderson L, Anderson T, Stenberg U. Determination of Tolterodine and the hydroxymethyl metabolite in plasma, serum and urine using gas chromatography-mass spectrometry. J Pharm Biomed Anal 1997; 16:155–65.
. Zhang B, Zhang Z, Tian Y, Xu F. High performance liquid chromatography-electro spray ionization mass spectrometric determination of Tolterodine tartarate in human plasma. J Chromatogr B 2005;824:92–8.
. Dwibhashyam VS, Keerthi P, Ratna JV, Nagappa AN. Reverse-phase, high performance liquid chromatographic method for the determination of Tolterodine Tartarate in routine Quality control sample. J Pharm Sci Technol 2009;63:234–39
. Dhirendra K, Lewis S, Udupa N and Atin K, Solid dispersions: A Review, Pak. J.Pharm. sci, 22(2), 2009; 234-246.
. Sai Lakshmi Jyothirmai K, Sireesha C, Gowthami BB: Formulation And Invitro Evaluation Of Tolteridone Tartarate Solid Dispersions Using Different Polymers. IAJPS 2017, 4 (10), 3736-3744 SSN 2349-7750.
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