Spectrophotometric Determination of Zolmitriptan in Pure Form and in Tablets through Charge Transfer Complex Reaction (original) (raw)
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Two simple, sensitive and extraction-free spectrophotometric methods have been developed for the determination of zolmitriptan (ZMT) in pure form and in pharmaceutical formulations. The methods are based on the formation of yellow coloured ion-pair complexes between ZMT and two sulphonphthalein acid dyes, bromocresol green (BCG) method (A) and bromocresol purple (BCP) method (B) with absorption maximum at 411 nm and 403 nm for BCG and BCP, respectively. The stoichiometry of the complex in either case was found to be 1: 1. Reaction conditions were optimized to obtain the maximum colour intensity. Beer's law was obeyed in the concentration ranges of 0.5–15.0and 0.375–12.0 μg/mL with BCG and BCP, respectively. The limits of quantification (LOQ) were 0.212 and 0.144 μg/mL for BCG and BCP methods, respectively. molar absorptivity (Ɛ) values were 24795, and 34548 L/moL.cm for BCG and BCP methods, respectively.The proposed methods have been applied successfully to the analysis of ZMT in pure form and in its dosage forms and no interference was observed from common excipients present in pharmaceutical formulations. Statistical comparison of the results with the reference method showed excellent agreement and indicated no significant difference in accuracy and precision.
Extractive spectrophotometric methods for determination of zolmitriptan in tablets
Journal of AOAC International
Two simple and sensitive extractive spectrophotometric methods have been developed for determination of zolmitriptan (ZTP) in tablets. These methods are based on the formation of yellow ion-pair complexes between ZTP and tropaeolin OO (TPOO) and bromothymol blue (BTB) in citrate-phosphate buffer of pH 4.0 and 6.0, respectively. The formed complexes were extracted with dichloromethane and measured at 411.5 and 410 nm for TPOO and BTB, respectively. The best conditions of the reactions were studied and optimized. Beer's law was obeyed in the concentration ranges of 2-20 and 1.5-17 microg/mL with molar absorptivities of 1.42 x 10(4) and 1.60 x 10(4) L/mol/cm for the TPOO and BTB methods, respectively. Correlation coefficients were 0.9998 and 0.9999 for TPOO and BTB methods, respectively. Limits of detection of the TPOO and BTB methods were 0.341 and 0.344 microg/mL, respectively, and the limits of quantitation were 1.034 and 1.051 microg/mL, respectively. Sandell's sensitivity ...
Journal Chinese Chemical Society Taipei, 2002
A simple, rapid, cost effective and extraction-free spectrophotometric method has been developed for the determination of zolmitriptan in pharmaceutical raw and dosage forms. The method is based on the charge-transfer reaction of zolmitriptan in acetonitrile medium with 0.2% 2,3-dichloro-5,6-dicyano-1,4benzoquinone to form a colored product peaking at 555 nm. Beer's law is obeyed in the concentration range 10-250 mg mL -1 with molar absorptivity of 1.7´10 3 L mole -1 cm -1 . The effects of variables such as reagent concentration, time of reaction, color stability and interferences have been investigated to optimize the procedure. The results have been validated analytically and statistically. The proposed method has been successfully applied for the determination of zolmitriptan in pharmaceutical formulations. Results indicate that the method is accurate, precise and reproducible (relative standard deviation < 2%).
Validated Uv Spectroscopic Method for Estimation of Zolmitriptan from Tablet Formulations
International Journal of Biomedical and Advance Research, 2011
A simple, sensitive and specific UV spectrophotometric method was developed for the estimation of Montelukast Sodium in bulk and in tablet dosage form. The optimum conditions for the analysis of the drug were established. The wavelength maxima (λ max) for Montelukast Sodium were found to be 287.3nm. The linearity for this method was found to be in the range of 2-100 μg/ml. The method showed high sensitivity with reproducibility in results. The calibration curve was drawn by plotting graph between absorbance and concentration. Method showed a correlation coefficient (r) of 0.999. The regression equation of the curve was y = 0.034x + 0.004. This sensitive method was capable to recover accurately and precisely from 80 % level to 120 % level of target concentration. The proposed method may be suitably applied for the analysis of Montelukast Sodium in bulk and in tablet pharmaceutical formulation for routine analysis.
Analytical Method Development and Validation for the Estimation of Zolmitriptan by RP HPLC Method
2019
A rapid, simple, selective and precise UV-Visible Spectrophotometric method has been developed for the determination of metformin hydrochloride in bulk forms and tablet dosage formulations. The spectrophotometric detection was as per carried out at an absorption maximum of 232 nm using phosphate buffer of pH 6.8 as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for was linear over the selected concentration range 2 to 12μg/ml with a correlation coefficient of 0.994. The accuracy was carried out as per recovery study and found between 99.1 % to 100.45%. The results demonstrated that the excipients in the tablets did not interfere with the method and can be conveniently employed for routine quality control analysis of metformin in bulk and formulation.
A validated chiral LC method for the determination of Zolmitriptan and its potential impurities
Journal of Pharmaceutical and Biomedical Analysis, 2005
A new, accurate and reliable chiral HPLC method was developed for the determination of Zolmitriptan, (4S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl] methyl]-2-oxazolidinone an antimigraine agent and its potential impurities namely (4R)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl] methyl]-2-oxazolidinone [(R)-enantiomer] and (4S)-4-(4-aminobenzyl)-2-oxazolidinone (Imp-1) in pharmaceutical formulations and in bulk drugs. HPLC separation was carried out by normal phase chromatography with a mobile phase composed of hexane:isopropanol:methanol:diethylamine in the ratio (75:10:15:0.1, v/v/v/v) pumped at a flow rate of 1.0 ml/min on a Chiralpak AD-H column. Zolmitriptan and its potential impurities were baseline resolved in the optimized method. The presence of diethylamine in the mobile phase has played a key role in achieving chromatographic resolution between the enantiomers and also in enhancing chromatographic efficiency. The developed method was also found to be selective under exposed conditions UV light and 60 • C. The developed method was completely validated and proved to be robust. The values of the limit of detection (LOD) and limit of quantification (LOQ) of (R)-enantiomer and Imp-1 were 100, 250 ng/ml and 30, 1000 ng/ml, respectively, for 10 l injection volume. The validated method yielded good results regarding selectivity, linearity, precision, accuracy and ruggedness. Zolmitriptan sample solution and mobile phase are found to be stable for at least 24 h. The proposed method was found to be suitable and accurate for the quantitative determination of Zolmitriptan and its impurities namely (R)-enantiomer and Imp-1 in bulk drugs and commercial formulations.
Chromatographia, 2013
Accurate, sensitive, and precise high performance thin layer chromatographic (HPTLC) methods were developed and validated for the determination of sumatriptan and zolmitriptan in presence of their degradation products. Sumatriptan was separated from its degradation products and analyzed on TLC silica gel 60 F 254 plates using chloroform-ethyl acetate-methanol-ammonia (4:3: 3:0.1, v/v) as a developing system followed by densitometric measurement of the bands at 228 nm. Zolmitriptan was determined using chloroform-ethyl acetate-methanolammonia (3:3:3:1, v/v) as a developing system followed by densitometric measurement at 222 nm. The methods were validated over a range of 0.5-4 lg/spot for sumatriptan and 0.5-3 lg/spot for zolmitriptan. The proposed methods were successfully applied for the determination of the studied drugs in bulk powder and in their pharmaceutical formulations.
The study was focused toward synthesis, characterization and quantification of 3-Ethyl-indole impurity in Zolmitriptan formulations by Reverse Phase High Performance Liquid Chromatography method. The synthesis of a process related impurity of Zolmitriptan was successfully carried out by Fischer indole procedure. The impurity was purified by column chromatography. Characterization was done by I.R, 1 H-NMR, 13 C-NMR and GC-MS. Based on the spectral data, the structure of impurity was characterized as 3-Ethyl-indole. An efficient isocratic RP-HPLC was developed and validated according to ICH guidelines with respect to specificity, accuracy, linearity and precision. The validated HPLC method was used for detection and quantitation of 3-Ethyl-indole, a process related impurity of Zolmitriptan, from Zolmitriptan tablet formulations. The above method was found to be specific, accurate, precise, rugged and robust and can be used for routine analysis.
2019
A new simple, accurate and precise HPLC method have been developed and validated for estimation of Zolmitriptan in its pharmaceutical dosage form. In RP-HPLC method, a C18 column and methanol: water in the ratio of 75:25 (v/v %), pH adjusted to 3 using 10% orthophosphoric acid were used at a flow rate of 1.0 mL/min and detected at 222 nm. The retention time for zolmitriptan was found to be 3.6 min. The developed method was validated for linearity, precision, accuracy, specificity, LOD and LOQ as per ICH guidelines. Linearity was observed in the range of 10-50 μg/mL for zolmitriptan and correlation coefficient was found to be 0.9979. LOD and LOQ for Zolmitriptan were found to be 2.84 μg/mL and 8.62 μg/mL respectively. The % recovery was found to be 99.87%-101.57%. The method was applied for estimation of Zolmitriptan in its pharmaceutical dosage form. The assay result was found to be 95.98 ± 1.82 of percentage label claim of Zolmitriptan.
2021
A new simple, accurate and precise HPLC method have been developed and validated for estimation of Zolmitriptan in its pharma ceutical dosage form. In RP-HPLC method, a C18 column and methanol: water in the ratio of 75:25 (v/v %), pH adjusted to 3 using 10% orthophosphoric acid were used at a flow rate of 1.0 mL/min and detected at 222 nm. The retention time for zolmitriptan was found to be 3.6 min. The developed method was validated for linearity, precision, accuracy, specificity, LOD and LOQ as per ICH guidelines. Linearity was observed in the range of 10-50 μg/mL for zolmitriptan and correlation coefficient was found to be 0.9979. LOD and LOQ for Zolmitriptan were found to be 2.84 μg/mL and 8.62 μg/mL respectively. The % recovery was found to be 99.87%–101.57%. The method was applied for estimation of Zolmitriptan in its pharmaceutical dosage form. The assay result was found to be 95.98 ± 1.82 of percentage label claim of Zolmitriptan.