scholarly journals Development of difference spectrophotometric method for the estimation of leflunomide in tablet dosage form

2012 ◽  
Vol 18 (3) ◽  
pp. 407-410
Author(s):  
Prabu Lakshmana ◽  
Suriya Prakash ◽  
A. Shanmugarathinam

A new simple, accurate, precise, highly sensitive and reproducible difference spectrophotometric method for the determination of leflunomide in bulk and pharmaceutical dosage form is described. Difference spectroscopic method is based on the principle that leflunomide exhibit two different forms; in acidic and basic medium which differs in their absorption spectra. The difference spectra were obtained by reading the absorbance of leflunomide in 0.1N HCl in the reference cell and the absorbance of leflunomide in 0.1N NaOH in the sample cell and vice versa; in the difference spectrum maxima and minima were seen at 293.5nm and at 261.5nm respectively. The amplitude values were calculated, which was plotted against concentration. The method is found to be linear in the concentration range of 2-12 ?g/ml. The percentage recovery was found to be between the ranges from 98.92 % to 99.08 %. The proposed method was statistically validated and successfully applied for analysis of tablet dosage forms.

Author(s):  
VAIBHAV S KHODKE ◽  
GAME MD

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.


2009 ◽  
Vol 6 (3) ◽  
pp. 809-813
Author(s):  
K. Anandakumar ◽  
Nageswararao Pacha ◽  
J. Saminathan ◽  
R. Subathrai ◽  
Kumarasamy Gandla

A simple, precise and accurate difference spectroscopic method has been developed for the estimation of balsalazide in bulk and in pharmaceutical dosage form. The proposed method is based on the principle that balsalazide can exhibit two different chemical forms in basic and acidic medium that differ in the absorption spectra in basic and acidic medium. Since the drug was freely soluble in distilled water, a stock solution (1 mg/mL) was prepared with distilled water. Further dilution was made by using 0.1 M sodium hydroxide and 0.1 M hydrochloric acid separately. The maxima and minima in the difference spectra of balsalazide were at 460 nm and 354 nm, respectively. Difference in absorbance between these maxima and minima was calculated to find out the amplitude. This amplitude was plotted against concentration. Beer’s law is valid in the concentration range of 2-20 μg/mL. The results of analysis have been validated statistically and by recovery studies.


INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (01) ◽  
pp. 59-63
Author(s):  
K Gohil ◽  
◽  
B. Shah ◽  
B. Patel ◽  
P. Patel ◽  
...  

Difference spectroscopic method is based on the principle that tolperisone hydrochloride can exhibit two different absorption spectra in basic and acidic medium. A stock solution (1 mg/ml) was prepared with distilled water. Further dilution was made by using 0.1 N sodium hydroxide and 0.1 N hydrochloric acid separately. The maxima and minima in the difference spectra of tolperisone hydrochloride were at 231nm and 263nm, respectively. Difference in absorbance between these maxima and minima was calculated to find out the amplitude. This amplitude was plotted against concentration. Linearity was found in the concentration range of 10-50µg/ml. The LOD and LOQ of tolperisone hydrochloride were found to be 0.064µg/mL and 0.196µg/mL respectively. The percentage recovery study of the drug for the proposed method was found in the range of 99.31 - 99.94% for tolperisone hydrochloride. The proposed method is recommended for routine analysis since it is rapid, simple, precise and accurate.


Author(s):  
Surya Teja G. ◽  
Gurupadayya B. M. ◽  
Venkata Sairam K.

Objective: The aim of the study was to develop an easy, sensible and rapid method for the estimation of amikacin in both pure and marketed formulation using the spectrophotometric method.Methods: Due to lack of chromophoric group in the amikacin, it was derivatized with 0.1 mmol chloranillic acid reagent. For the estimation of amikacin, Shimadzu UV-1700 model spectrophotometer with UV probe software was used. The method was based simple on charge transfer complexation of the drug with a p-chloranilic acid reagent to give a purple coloured product which was measured at 524 nm against blank solution.Results: The derivatised product of amikacin was detected at a wavelength of 524 nm. Linearity was observed with the concentration range of 20-100 µg/ml with a regression coefficient of 0.9803. Results of all the parameters were within the acceptance criteria with % RSD less than 2.Conclusion: The spectroscopic method was validated as per ICH guidelines and was found to be applicable for routine quantitative analysis of amikacin in marketed formulations also. The results of linearity, precision, accuracy LOD and LOQ were within the specified limits. The method is highly sensitive, robust, reproducible and specific.


Author(s):  
Vaishnavi Dulange ◽  
G.B. Gajeli

UV spectroscopic method was developed for the estimation of Dolutegravir in bulk and Formulation.The UV spectrum of Dolutegravir in methanol and water mixture showed λ max at 254nm. Beer’s law is valid in the concentration range of 10-50µg/ml. This method was validated for linearity, accuracy, precision, LOD and LOQ. The method has demonstrated excellent linearity over the range of 10-50µg/ml with regression equation y = 0.030x + 0.008 and regression correlation coefficient r2= 0.998. Moreover, the method was found to be highly sensitive with LOD (2.056μg/ml) and LOQ (6.230μg/ml). Depending on results the given method can be successfully applied for assay of Dolutegravir in formulation.


INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (04) ◽  
pp. 50-54
Author(s):  
M. P Patel ◽  
◽  
M. R Patel ◽  
R Hasumati ◽  
M. N Noolvi ◽  
...  

A simple, accurate, precise, rapid, economical UV spectrophotometry method, dual wavelength spectrophotometry, has been developed and validated for estimation of Indapamide (IND) and Amlodipine besylate (AML) in combined tablet dosage form and can be used in routine analysis. In this method, the absorbance at 360 nm and 256 nm of AML were same and no interference of IND at 360 nm. was observed. So, absorbance difference at 256-360 is used for estimation of IND and absorbance at 360 nm used for AML. The method was found to be linear in the concentration range of 3-18 μg/mL for IND (r2>0.99962) and 10-60 μg/mL for AML (r2>0.99969). Mean assay was found to be 99.32% and 101.34% for IND and AML respectively. In first order derivative spectrophotometry, the absorbance at 237.4 nm (ZCP of AML) and 241 nm (ZCP of IND) were used for estimation of IND and AML respectively. The method was found to be linear in the concentration range of 1.5-9 μg/mL for IND(r2=0.99983) and 5-30 μg/mL for AML(r2=0.99966). Mean assay was found to be 99.72% and 100.28% for IND and AML respectively.


Author(s):  
Sunil More ◽  
Ashpak Tamboli ◽  
Snehal Patil ◽  
Amol Vhanmane

There is not a single analytical methods appeared in the literature for combined estimation of Amlodipine and Chlorthalidone in tablets dosage form. Attempts were made to develop a simple, precise and accurate Simultaneous UV spectroscopic method of Amlodipine and Chlorthalidone in bulk and Amlodac CH tablet dosage form by using simultaneous equation method. UV spectrophotometric method was developed and validated as per ICH guidelines using methanol as mobile phase. Amlodipine and Chlorthalidone individually follows the Beer-Lamberts law over concentration range 2.5-12.5μg/ml and 6.25-31.5μg/ml, Regression of coefficient was found to be r2=0.999 and r2=0.999 respectively. The percentage recovery was found in the range of 98% to 102% at three different levels. The proposed method was successfully applied for the determination of Amlodipine and Chlorthalidone in tablets dosage form as per ICH guidelines the result of the analysis were validated statistically and were found to be satisfactory.


Author(s):  
Suyash Ingle ◽  
Varsha Tegeli ◽  
Avinash Birajdar ◽  
Vinod Matole ◽  
Sagar Adlinge ◽  
...  

Objective: A new, simple, sensitive, precise and reproducible UV spectroscopic method was developed for the estimation of Lignocaine Hydrochloride in bulk and Semisolid Formulation. Methods: The UV spectrum of Lignocaine Hydrochloride in RO water showed λ max at 228.8nm. Beer’s law is valid in the concentration range of 20-100µg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 20-100µg/ml with regression equation y = 0.0097x + 0.023 and regression correlation coefficient r2= 0.9992. Moreover, the method was found to be highly sensitive with LOD (3.55μg/ml) and LOQ (10.75μg/ml). Conclusion: Depending on results the given method can be successfully applied for assay of Lignocaine Hydrochloride in Semisolid formulation.


2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Doddi Srilatha ◽  
Mahesh Nasare ◽  
Borra Nagasandhya ◽  
Valluri Prasad ◽  
Prakash Diwan

A simple, rapid, precise and highly selective spectrophotometric method was developed for simultaneous estimation of Hesperidin and Diosmin in tablet dosage form. This method, involves the measurement of absorbances of Hesperidin and Diosmin at the wavelengths of 285 nm (λmax of Hesperidin) and 268 nm (λmax, of Diosmin). The UV spectra’s of Hesperidin and Diosmin prepared in different solvents water, methanol, and acetonitrile and 0.2 N sodium hydroxide were recorded. These two drugs showed good absorbances when dissolved in 0.2 N NaOH. Hence 0.2 N NaOH was selected as the solvent for the method. Two wavelengths 285 and 268 nm were selected which are λmax of two drugs Hesperidin and Diosmin, respectively. Different concentrations of Hesperidin (5–50 μg/mL) and Diosmin (2–24 μg/mL) and a mixture of Hesperidin and Diosmin were prepared, scanned and absorbances were noted at the two wavelengths were fixed for the study. The method showed good reproducibility and recovery with % RSD less than 2. The LOD of Hesperidin and Diosmin was found to be 0.139 μg/mL and 0.048 μg/ml and LOQ of Hesperidin and Diosmin was found to be 0.42 μg/mL and 0.147 μg/mL, respectively. Thus the proposed method was found to be rapid, specific, precise, accurate and cost effective quality control tool for the routine analysis of Hesperidin and Diosmin in bulk and combined dosage form.


Author(s):  
Chandani Makvana ◽  
Satyajit Sahoo

A simple, rapid, precise, accurate and sensitive spectrophotometric method has been developed for the simultaneous estimation and validation of Nebivolol Hydrochloride (NEB) and Valsartan (VAL) in pure and combined tablet dosage forms. Pure drug samples of NEB and VAL were dissolved in 67 mM Phosphate buffer pH 6.8 with 0.5% sodium dodecyl sulphate (SDS) and found to have absorbance maxima at 280 nm for NEB and 250 nm for VAL, respectively. The linearity lies between 10-70μg/ml for NEB and 10-60μg/ml for VAL in this method. The correlation coefficient (r2) was found to be 0.9965 for NEB and 0.9960 for VAL. The % recoveries obtained were 95.65%-109.85% for NEB and 97.42%-101.43% for VAL. The % RSD found 0.271%-1.490% for intraday and 0.334%-1.917% for interday for NEB and 0.188%-0.944% for intraday and 0.392%-1.197% for interday for VAL. The limit of detection and limit of quantitation for NEB were found to be 4.608μg/ml and 13.965μg/ml respectively and the limit of detection and limit of quantitation for VAL were found to be 4.348μg/ml and 13.178μg/ml respectively. Simultaneous calibration of both drugs in 67 mM Phosphate buffer pH 6.8 with 0.5% SDS shows that λmax of one drug does not interfere on the λmax of other drug. Recovery study was performed to confirm the accuracy of the method. The results of analysis have been validated statistically by recovery studies as per International Conference on Harmonization guidelines. The method showed good reproducibility and recovery with % RSD Lessthan 2. Hence, this proposed method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of NEB and VAL in pure and combined tablet dosage form.


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