DEVELOPMENT AND VALIDATION OF DIFFERENCE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF TOLPERISONE HCL IN BULK AND PHARMACEUTICAL DOSAGE FORM

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.

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.


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):  
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.


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.


Author(s):  
Shaheen Begum ◽  
Jahnavi. B ◽  
Nameera Jabeen ◽  
Umema Naaz. T ◽  
Sandhya. M

In the present work, simple and sensitive UV spectroscopic method has been developed for the quantitative estimation of Evening Primrose Oil in efem capsule. Cyclohexane was used as solvent. In the range of 100-500μg/ml, the linearity of Evening Primrose Oil shows a correlation co-efficient of 0.999. The UV detection wavelength was 233nm. The percentage RSD for precision and accuracy of the method was found to be less than 2%(LOQ) of 23μg/ml and (LOD) of 7.5μg/ml. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Evening Primrose Oil and in formulation dosage form.


INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 17-21
Author(s):  
A Kukrety ◽  
◽  
K. Kohli ◽  
M. Singhal ◽  
C Dhal ◽  
...  

A simple, rapid, accurate, precise and reproducible UV spectroscopic method has been developed for the simultaneous estimation of pitavastatin calcium and fenofibrate in bulk and pharmaceutical dosage form. The method is based on simultaneous equation method. Pitavastatin calcium and fenofibrate have absorption maxima (λmax) at 245 nm and 286 nm respectively. Beer’s law was obeyed in the concentration range of 2-12 μg/mL and 32-192 μg/mL for pitavastatin calcium and fenofibrate, respectively. The recovery studies are indicative of accuracy of method and are found in between 97.66-107.22% and 103.33-110.55% for pitavastatin calcium and fenofibrate, respectively, at three different levels of standard additions. Precision studies showed satisfactory results.


Author(s):  
BHAGYASHRI S. SHINDE ◽  
M. S. KALSHETTI ◽  
ANJALI P. KOKANE

Objective: To developed and validated UV spectrophotometric method for the estimation of ipratropium bromide in API and pharmaceutical formulation. Methods: Methanol is used as a solvent and the absorbance of the drug was measured at absorbance’s maxima of ipratropium bromide max is 214 nm. Results: Maximum absorbance obtained in 214 nm. Calibration curve plotted in concentration range 20-120 µm/ml exhibit the linearity relationship with line equation y=.0.0091x+0.1503 The Accuracy was found to be 99.7-100.2%, the precision %RSD= 0.08613-0.2668, and the LOD and LOQ is 6.33, 19.19. The method was found to comply all the validation parameters as per the ICH guideline indicating the sensitivity of the method analyte. Conclusion: This method is used as satisfactory for the routine analysis of ipratropium bromide in API and pharmaceutical dosage forms.


Sign in / Sign up

Export Citation Format

Share Document