CRITICAL REVIEW OF CHROMATOGRAPHIC AND SPECTROPHOTOMETRIC METHODS AND APPLICATION OF UV- AUC TECHNIQUE FOR SIMPLE, RAPID, QUANTITATIVE ESTIMATION OF ATAZANAVIR SULFATE

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (05) ◽  
pp. 26-36
Author(s):  
P. S. Bobade ◽  
◽  
S. B. Ganorkar
Keyword(s):  
Quantitative Estimation ◽  
Analytical Techniques ◽  
Solvent System ◽  
Spectrophotometric Analysis ◽  
Calibration Plot ◽  
Minimal Cost ◽  
Spectrophotometric Methods ◽  
Atazanavir Sulfate ◽  
Development And Validation ◽  
Uniform Area

Spectrophotometric analysis has proven to be one of the most referred analytical techniques available; as the enlarged globalization of the pharmaceutical market has reduced the availability of quality pharmaceuticals at minimal cost. Authors have made an attempt for development and validation of simple UV- spectrophotometric area under curve (UV -AUC) method for quantitative estimation of atazanavir sulfate in bulk and in a pharmaceutical formulation. To enhance accuracy, additional attempts were made for the measurement of uniform area around the wavelength maximum (248 nm) and in between the designated wavelengths (238 nm and 260 nm). The mixture of methanol and water in a proportion of 30:70 v/v was selected as a solvent system. Efficient correlation between the concentration and corresponding response was maintained by measuring the uniform area under the peak obtained at the wavelength maximum. The calibration plot for the method was constructed by plotting the values for AUC obtained for the concentration range of 6 - 36 μg/mL with a correlation coefficient of 0.999. Developed method was validated on the basis of ICH Q2 R1 guideline. The method depicted good reproducibility with percent RSD less than 2.0. Estimation of atazanavir sulfate by aforementioned method in bulk and capsules was carried out efficiently.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DULOXETINE

2019 ◽  
pp. 27-31
Author(s):  
LIPSA SAMAL ◽  
AMARESH PRUSTY
Keyword(s):  
Spectrophotometric Method ◽  
Spectroscopic Method ◽  
Solvent System ◽  
Spectrophotometric Analysis ◽  
Thiophene Derivative ◽  
Experimental Conditions ◽  
Relative Standard ◽  
Uv Visible ◽  
Development And Validation

Objective: The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of duloxetine, which is a thiophene derivative and a selective neurotransmitter reuptake inhibitor for serotonin, norepinephrine, and to lesser degree dopamine. Methods: The UV Spectrophotometric analysis was performed using Shimadzu UV-1800 and Shimadzu UV-1700 spectrophotometer by using solvent system acetonitrile and water in the ratio of 8:2. Detection was performed at a wavelength of 290 nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters linearity, accuracy, precision, ruggedness, and robustness, LOD and LOQ. Results: The UV Spectrophotometric method was found linear in the range of 10-50 μg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries were found to be higher than 99% in all experimental conditions. Conclusion: Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of Duloxetine for routine analysis.

scholarly journals Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

2019 ◽  
Vol 65 (2) ◽  
pp. 55-59 ◽  
Author(s):  
Béla Kovács ◽  
Réka Molnár ◽  
Előd Ernő Nagy ◽  
Éva Katalin Kelemen ◽  
Blanka Székely-Szentmiklósi ◽  
...  
Keyword(s):  
Spectrophotometric Method ◽  
Strontium Ranelate ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Spectrophotometric Analysis ◽  
Pharmaceutical Dosage Form ◽  
Spectrophotometric Methods ◽  
Limit Of Quantitation ◽  
Method Accuracy ◽  
Development And Validation

AbstractObjective: The present work offers a fast, reliable and easy UV spectrophotometric method for the assay of strontium ranelate from bulk samples and pharmaceutical dosage form.Methods: The proposed method uses 0.1% V/V trichloroacetic acid as dissolution medium for spectrophotometric analysis, by signal detection at 321 nm. The method was validated according to the currently in-force international guidelines for linearity, accuracy, precision, robustness, limit of detection and quantification.Results: The method was found to be linear in the range of 5-100 µg mL-1 (R2 > 0.999). Method accuracy was found in-between 98.87-100.41%, showing good linear correlation as well (R2 = 0.9997). The concentrations for limit of detection and limit of quantitation were found 1.13 µg mL-1 and 3.77 µg mL-1, resp. The proposed method showed good intra- and interday precision, with low RSD values of 0.53-1.24% and 1.11%, resp.Conclusions: Stability studies performed by both HPLC and UV spectrophotometric methods revealed that the active substance is highly susceptible to acidic hydrolysis, oxidation and exposure to high temperature.

scholarly journals Development and Validation of Stability Indicating Assay Method for Determination of Felodipine in Tablet Dosage Form

2018 ◽  
Vol 10 (4) ◽  
Author(s):  
Narendra G. Patre ◽  
S. S. Patil
Keyword(s):  
Mobile Phase ◽  
Quantitative Estimation ◽  
Assay Method ◽  
Calibration Plot ◽  
Quality Control Testing ◽  
Tablet Formulations ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

A simple and sensitive, HPTLC method has been developed for the quantitative estimation of felodipine in it’s single component tablet formulation. The separation was carried out on Merck aluminium plates precoated with silica Gel 60 F254 using n -hexane: ethyl acetate in the ratio of 6:4 (v/v) as mobile phase. Felodipine showed Rf value of 0.53 ± 0.027 and was scanned at 366 nm using Camag TLC Scanner 3. The linear regression data for the calibration plot showed a good relationship with r=0.9792. The method was validated for precision and recovery. The limits of detection and quantification were 23.54 and 71.33 ng/spot respectively. The developed method was successfully used for the assay of felodipine tablet formulations. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.

scholarly journals Development and Validation of HPTLC Method for Quantification of Solanesol in Various Parts of Nicotiana tabacum Collected from Different Geographical Regions of India

2018 ◽  
Vol 10 ◽  
pp. 29-35
Author(s):  
Sunil Kaushik ◽  
Mohammad Asif
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Solvent System ◽  
Calibration Plot ◽  
Leaf Sample ◽  
Geographical Regions ◽  
Hptlc Method

Solanesol is the starting material for many high value biochemicals, including Co-enzyme Q10 and vitamin-K analogues. The aim of the current study was to develop and validate a reliable and fast analytical procedure for the determination of solanesol in Nicotianatabacum using high-performance thin layer chromatography (HPTLC) method. The method was developed on TLC aluminium plates precoated with silica gel 60F-254 using solvent system hexane: ethyl acetate (5:1, v/v), which gives compact spot of solanesol (Rf value 0.41 ± 0.02). Densitometric analysis of solanesol was carried out in the absorbance mode at 210 nm. The linear regression analysis data for the calibration plot showed good linear relationship with r = 0.9978 with respect to peak area, in the concentration rang 100-5000 ng per spot of solanesol. The limit of detection and quantification were 13 and 30 ng per spot, respectively. The proposed method was applied for quantitative estimation of solanesol in different parts of Nicotianatabacum from different geographical regions in India, which showed that maximum amount of solanesol was found to be present in leaf sample collected from Karnataka i.e. 3.52 mg/g. Statistical analysis proved that the method is repeatable, selective and accurate for the estimation of solanesol in Nicotianatabacum.

scholarly journals Development and validation of UV-spectrophotometric methods for quantitative estimation of Prothionamide in pure and pharmaceutical dosage forms

2015 ◽  
Vol 4 (7) ◽  
pp. 402-404 ◽  
Author(s):  
Sujit Kumar Debnath ◽  
S. Saisivam ◽  
Dillip Kumar Dash ◽  
Monalisha Debnath
Keyword(s):  
Quantitative Estimation ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
Routine Practice ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Validation Parameters ◽  
Bulk Drug ◽  
Development And Validation

UV Spectrophotometric method was developed and validated for the quantitative determination of Prothionamide in bulk drug and in pharmaceutical formulations. Prothionamide shows the maximum absorbance at 288 nm in phosphate buffer (pH 7.4). Prothionamide follows Beer’s law in the concentration range of 4-20 µg/ml (r2 = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.406 and 1.229 µg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Prothionamide in assay of bulk drug and pharmaceutical formulations.International Current Pharmaceutical Journal, June 2015, 4(7): 402-404

Method Development and Validation of Spectrophotometric Methods for The Estimation of Rizatriptan Benzoate in Pure and Pharmaceutical Dosage Form

2021 ◽  
pp. 6003-6006
Author(s):  
Pushpa Latha E. ◽  
Sailaja B.
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rizatriptan Benzoate ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Analytical UV derivative spectrophotometric method was developed and validated to quantify Rizatriptan Benzoate in pure drug and tablet dosage form. Based on the spectrophotometric characteristics of Rizatriptan Benzoate, a signal of zero (225nm), first (216nm), second (237nm), third (233nm), fourth (231nm) order derivative spectra were found to be adequate for quantification. The methods obeyed Beer's law in the concentration range of (0.1-360µg/ml) with square correlation coefficient (r2) of 0.999. The mean percentage recovery was found to be 100.01 ± 0.075. As per ICH guidelines the results of the analysis were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and were found to be satisfactory.

Development and Validation of UV-Visible Spectrophotometric method for the Estimation of Curcumin and Tetrahydrocurcumin in Simulated Intestinal Fluid

2021 ◽  
pp. 2971-2975
Author(s):  
Jai Bharti Sharma ◽  
Sherry Sherry ◽  
Shailendra Bhatt ◽  
Vipin Saini ◽  
Manish Kumar
Keyword(s):  
Drug Release ◽  
Spectrophotometric Method ◽  
Tween 80 ◽  
Solvent System ◽  
Intestinal Fluid ◽  
Simulated Intestinal Fluid ◽  
Validation Parameters ◽  
Administration Method ◽  
Uv Visible ◽  
Development And Validation

Background: Due to solubility issues of curcumin and tetrahydrocurcumin, there is a need for the development of a UV-Visible spectrophotometric method that can estimate the drug release precisely and accurately. The addition of surfactant in the dissolution medium in low concentration achieved bio-comparable surface activity and can be used to estimate the drug release from formulations by avoiding sink conditions. Objective: The purpose of the present investigation was to develop a simple and précise UV-Visible spectrophotometric method for the determination of curcumin and tetrahydrocurcumin after oral administration. Method: A UV-Visible spectrophotometric method was developed using an appropriate solvent system for the estimation of curcumin and tetrahydrocurcumin. The solvent system having simulated intestinal fluid and particular concentration of surfactant was selected and further validated according to guidelines of the international conference on harmonization (ICH), the analytical parameter like linearity, precision and accuracy, etc. were studied. Results: Simulated intestinal fluid pH 7.4 with tween 80 at 1 % concentration satisfied all the conditions relative to peak quality at the stated wavelength for curcumin and intestinal fluid pH 7.4 with tween 80 at 0.5% concentration satisfied all the conditions relative to Peak quality at the stated wavelength for tetrahydrocurcumin. The developed methods were found within the range of all the validation parameters. Conclusion: The proposed method was found to be very simple and precise and can be used for routine quantitative analysis of curcumin and tetrahydrocurcumin.

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