Validated UV-Visible spectrometry using water as a solvent for determination of chloroquine in tablet samples

2019 ◽  
Author(s):  
Chem Int

Methods reported including the official methods for determination ofchloroquine in tablet samples use carcinogenic organic solvents. In this study,UV-Vis spectrometry using water as a solvent was developed for determination ofchloroquine phosphate in pharmaceutical tablet dosage forms. The method wasvalidated according to the International Conference on Harmonization (ICH) andUSP guidelines. The absorbance of chloroquine phosphate in distilled water at max of 343 nm showed linear dependence on concentration in the range 10.88-30.56μg mL-1 with determination coefficient of 0.99972. Recovery results in the range98.79–101.20% and low coefficient of variation values for intra-day and interdayprecisions (0.37% and 0.76%, respectively) showed the accuracy andreproducibility of the method. The method was used for determination ofchloroquine phosphate in tablet formulations of different brands. Results in therange 100.63–103.52% of the labeled chloroquine phosphate in tabletformulations confirmed the applicability of the developed method for real sampleanalysis. Hence, the developed UV-Vis method using environmentally friendlywater as a solvent, with an excellent accuracy and precision showed that thedeveloped method can be a potential substituent for the official referencemethods.

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy

Abstract Background We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min. Results The chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery. Conclusion The developed stability-indicating liquid chromatography process was well applied to established tablet formulations.


Author(s):  
Zeinab Adel Nasr ◽  
Noha S. Said ◽  
Sawsan A. Abdel-Razeq

Aims: Two spectrophotometric methods were developed and validated for the determination of sofosbuvir in presence of its alkaline degradate. Study Design: Ratio difference and ratio derivative methods were assisted for determination of sofosbuvir in presence of its alkaline degradate, laboratory-prepared mixtures and in tablet dosage forms. Place and Duration of Study: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al - Azhar University, between December 2019 and January 2020. Methodology: Two analytical methods were achieved and validated for the quantitative determination of Sofosbuvir in presence of its alkaline degradate. The first method was ratio difference (RD) method, where the UV absorption spectra of different concentrations of sofosbuvir were divided by the spectrum of a certain concentration (15 µg mL-1) as a devisor of its alkaline degradate to get the ratio difference spectra. Afterwards, the peak amplitudes difference between 253.7 and 243.5 nm were measured. The second method was the ratio derivative (1DR) method, where the first derivative of the ratio spectra (1DR) was obtained and its amplitude was measured at 247 and 268 nm. Good linearity was obtained over the concentration range of 3-15 µg mL-1 for the proposed methods. The proposed procedures were adopted for the selective determination of intact Sofosbuvir in presence of up to 80% of its degradation product. Sofosbuvir was exposed to different conditions as alkaline, acidic and oxidative degradation. Results: The proposed methods were developed and validated with good linearity range of 3-15 µg mL-1 for both methods, and also with good accuracy and precision. And the obtained results were statistically compared to those obtained by the reported method. Conclusion: Sofosbuvir was successfully determined by the proposed ratio difference and ratio derivative methods in bulk powder, laboratory prepared mixtures and tablet dosage form with good accuracy and precision. The methods were validated according to ICH guidelines. The results obtained were compared with those of the reported method and were found to be in good agreement.


Author(s):  
Sawsan A. Abdel-Razeq ◽  
Zeinab Adel Nasr ◽  
Noha S. Said

Aims: Two simple and sensitive stability- indicating methods were developed and validated for the quantitative determination of sofosbuvir in presence of its degradation products. Study Design: Ultra high performance liquid chromatography (UPLC), High performance thin layer chromatography (HPTLC) are developed for determination of sofosbuvir in presence of its degradation products, laboratory-prepared mixtures and in tablet dosage forms. Place and Duration of Study: Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, between August 2018 and March 2019. Methodology: Two simple and sensitive stability- indicating methods were developed and validated for the quantitative determination of Sofosbuvir in presence of its degradation products. The first method was an Ultra Performance Liquid Chromatography (UPLC) method, in which efficient separation was carried out on phenomenex kinetex 2.6 μm C18 100 A column using a mobile phase consisting of filtered and degassed mixture of 0.1% ortho-phosphoric acid in water and methanol with the ratio of (40:60% v/v) adjusted to pH 3.5, at a flow rate of 1 mL min-1 and UV detection at 260 nm at ambient temperature. The second method is a high performance- thin layer chromatographic one (HPTLC) in which chromatographic separation was performed on silica gel 60 F254 plates, with methanol – chloroform – ammonia (2.5: 6: 1.5 % v/v/v) as a developing system followed by densitometric determination at 261 nm. Sofosbuvir was subjected to stress conditions including alkaline, acidic and oxidative degradation. Results: Beer’s law was obeyed over the range of 1-20 μg mL–1 for UPLC and 2-12 μg / spot for HPTC with good accuracy and precision using the two procedures, respectively. Results obtained was statistically analysed and found to be in accordance with those given by the reported method. Conclusion: The proposed methods were successfully applied for the determination of sofosbuvir in bulk powder, laboratory prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The methods were validated according to ICH guidelines. The results obtained were compared with those of the reported method and were found to be in good agreement.


2010 ◽  
Vol 7 (3) ◽  
pp. 833-836 ◽  
Author(s):  
Mohammad Yunoos ◽  
D.Gowri Sankar ◽  
B.Pragati Kumar ◽  
Shahul Hameed

A simple, sensitive, precise and highly accurate UV spectrophotometric method has been developed for the determination of tadalafil in bulk and tablet dosage form. Solution of tadalafil in methanol shows maximum absorbance at 284 nm. Beer’s law was obeyed in the concentration range of 2-20 mcg mL-1with 1.65x104mol-1cm-1, the slope, intercept, correlation coefficient, detection and quantitation limits were also calculated. The proposed method has been applied successfully for the analysis of the drug in pure and in its tablets dosage forms. Result of percentage recovery and placebo interference shows that the method was not affected by the presence of common excipients. The method was validated by determining its sensitivity, accuracy and precision which proves suitability of the developed method for the routine estimation of tadalafil in bulk and solid dosage form.


2009 ◽  
Vol 6 (3) ◽  
pp. 814-818 ◽  
Author(s):  
M. Ganesh ◽  
C. V. Narasimharao ◽  
A. Saravana Kumar ◽  
K. Kamalakannan ◽  
M. Vinoba ◽  
...  

A simple, sensitive, highly accurate UV spectrophotometric method has been developed for the determination of valacyclovir in bulk and tablet dosage form. Solution of valacyclovir in 0.1N HCl shows maximum absorbance at 255 nm. Beer’s law was obeyed in the concentration range of 5-25 mcg mL-1with 1.0910x104mol-1cm-1, the slope, intercept, correlation coefficient, detection and quantitation limits were also calculated. The proposed method has been applied successfully for the analysis of the drug in pure and in its tablets dosage forms. Result of percentage recovery and placebo interference shows that the method was not affected by the presence of common excipients. The percentages assay of valacyclovir HCl in tablet was 99.82%. The method was validated by determining its sensitivity, accuracy and precision which proves suitability of the developed method for the routine estimation of valacyclovir in bulk and solid dosage form.


2010 ◽  
Vol 7 (s1) ◽  
pp. S344-S348 ◽  
Author(s):  
R. Rote Ambadas ◽  
P. Pingle Sunita

Two simple, economic and accurate UV spectrophotometric methods have been developed for determination of gemifloxacin mesylate in pharmaceutical tablet formulation. The first UV-spectrophotometric method depends upon the measurement of absorption at the wavelength 263.8 nm. In second area under curve method the wavelength range for detection was selected from 268.5-258.5 nm. Beer’s law was obeyed in the range of 2 to 12 μgmL-1for both the methods. The proposed methods was validated statistically and applied successfully to determination of gemifloxacin mesylate in pharmaceutical formulation.


2016 ◽  
Vol 4 (4) ◽  
pp. 145-151 ◽  
Author(s):  
P Ravisankar ◽  
G Devala Rao ◽  
M Krishna Chaitanya ◽  
Ch Devadasu ◽  
G Sudhakar Saibabu

2013 ◽  
Vol 2013 ◽  
pp. 1-6
Author(s):  
Vishnu P. Choudhari ◽  
Sanket R. Parekar ◽  
Subhash G. Chate ◽  
Pradeep D. Bharande ◽  
Rajiv R. Singh ◽  
...  

A simple, economical, precise, and accurate new UV-visible spectrophotometric baseline manipulation method for simultaneous determination of tenofovir disoproxil fumarate (TE) and emtricitabine (EM) in combined tablet dosage form has been developed. The method is based on baseline manipulation (difference) spectroscopy where amplitudes at 261 and 289.9 nm were selected to determine TE and EM, respectively, in combined formulation, and distilled water was used as solvent. Both drugs obey Beer’s law in the concentration ranges of 4–20 μg/mL for TE and 6–30 μg/mL for EM. The results of analysis have been validated statistically, and recovery studies confirmed the accuracy of the proposed method which was carried out by following the ICH guidelines.


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