Suganya, M S (2007) Simultaneous Estimation of Finateride and Tamsulosin Hydrochloride in Pharmaceutical Dosage forms by Uv Spectrophotometric, RP-HPLC and HPTLC Methods. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.
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Abstract
The simultaneous quantification of Finasteride and Tamsulosin hydrochloride in pharmaceutical dosage forms, there is no documentary evidence available. At the outset, it was aimed to develop a rapid, sensitive, precise and accurate method for the pharmaceutical dosage forms. The objective of the study is as follows: Development of rapid, sensitive and accurate reverse phase RP-HPLC method for simultaneous estimation of Finasteride & Tamsulosin hydrochloride in pharmaceutical dosage forms. Development of rapid, sensitive and accurate High Performance Thin Layer Chromatographic method for simultaneous estimation of Finasteride & Tamsulosin hydrochloride in pharmaceutical dosage forms. Development of UV Spectrophotometric method for simultaneous estimation of Finasteride & Tamsulosin hydrochloride in pharmaceutical dosage forms by Q-absorbance ratio method. This study was focused in the method development for the simultaneous quantification of the pharmaceutical dosage form of Finasteride and Tamsulosin Hydrochloride. It was successful in achieving three different analytical techniques, namely, 1) High Performance Liquid Chromatography (HPLC), 2) High Performance Thin Layer Chromatography (HPTLC) and 3) Q-absorbance ratio method by UV Spectroscopy for the routine analysis for the combination dosage forms. The HPLC method, proved to have high selectivity, precision and accuracy. The drugs were eluted by C18, ODS column (Phenomenex), using Acetonitrile: Buffer (pH adjusted to 3.0 ± 0.2 with Orthophosphoric acid) in the ratio of 60:40 as mobile phase and UV detector at wavelength of 230nm. The retension time of Finasteride was 7.11 minutes and that of Tamsulosin Hydrochloride was 2.65 minutes. The HPTLC method developed for the formulation proved to be easiest and quick method of analysis. The method was developed using CAMAG HPTLC scanner and Linomat applicator, with a mobile phase combination of Toluene: Chloroform: Methanol: Triethylamine in the ratio of 7:2:1:2 at 230nm as scanning wavelength. The retardation factor of Tamsulosin Hydrochloride was 0.35 and that of Finasteride was 0.78. 77 Q-absorbance ratio method developed for the dosage form, proved to be easy and economical method for the rapid evaluation of drug components utilizing λmax of Tamsulosin Hydrochloride and Isoabsorptive point of both the drugs. The linearity data was subjected to linear regression analysis in order to confirm the linear relationship between concentration and response. All the three analytical techniques developed were subjected to method validation as specified in ICH guidelines. The analytical performance characteristics were established and the values were found to be within the specified limits as recommended. Quantitative estimation was subjected to statistical analysis. %RSD value obtained was below 2 indicates precision of the method. The low standard error value indicates accuracy of the method. Thus the methods developed were found to be simple, specific, precise, linear, accurate and were reliable & reproducible for simultaneous quantification of Finasteride and Tamsulosin Hydrochloride in pharmaceutical dosage forms.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Finateride; Tamsulosin Hydrochloride; Pharmaceutical Dosage; Uv Spectrophotometric; RP-HPLC; HPTLC Method |
| Subjects: | PHARMACY > Pharmaceutical Chemistry |
| Depositing User: | Ravindran C |
| Date Deposited: | 17 Aug 2017 07:37 |
| Last Modified: | 18 Aug 2017 03:05 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/2668 |
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