scholarly journals Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION

2019 ◽  
pp. 275-279
Author(s):  
VAIBHAV S KHODKE ◽  
GAME MD
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Quality Criteria ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Good Agreement

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.

scholarly journals Simultaneous UV Spectrophotometric Estimation of Amlodipine and Chlorthalidone in Bulk and Combined Tablet Dosage Form

2019 ◽  
pp. 468-472
Author(s):  
Sunil More ◽  
Ashpak Tamboli ◽  
Snehal Patil ◽  
Amol Vhanmane
Keyword(s):  
Spectrophotometric Method ◽  
Mobile Phase ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Simultaneous Equation ◽  
Ich Guidelines ◽  
Combined Estimation ◽  
Tablet Dosage ◽  
Different Levels

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.

scholarly journals DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRICMETHOD FOR QUANTITATIVE ESTIMATION OF GLIPIZIDEIN PHARMACEUTICAL DOSAGE FORM

2020 ◽  
pp. 104-107
Author(s):  
ANUJA SURYAWANSHI ◽  
AFAQUEANSARI ◽  
MALLINATH KALSHETTI
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
The Novel ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Novel Method ◽  
Bulk Drug ◽  
Development And Validation

Objective: The present work is aimed to develop a simple, rapid, selective and economical UV spectrophotometric method for quantitative determination of Glipizideinbulk and pharmaceutical dosage form. Methods: In this method Dimethyl Form amide (DMF) was used as solvent, the absorption maxima was found to be275 nm in DMF. The developed method was validated for linearity, accuracy, precision, ruggedness, robustness, LOD and LOQ in accordance with the requirements of ICH guideline. Results: The linearity was found to be 10-60 µg/ml having linear equation y=0.017x-0.006 with correlation coefficient of 0.997. The% recovery was found to be in the range of 98.7-100%. The % RSD for intra-day and inter-day precision was found to be 0.569923 and 0.40169 respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be3.06 µg/ml and 9.27 µg/ml respectively. Conclusion: The developed method was validated as per ICH Q2(R1) guidelines. The novel method is applicable for the analysis of bulk drug in its pharmaceutical dosage form.

Method Development and Validation of Evening Primrose oil and its Pharmaceutical dosage form by Simple UV- Spectrophotometric Method

2021 ◽  
pp. 133-138
Author(s):  
Shaheen Begum ◽  
Jahnavi. B ◽  
Nameera Jabeen ◽  
Umema Naaz. T ◽  
Sandhya. M
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Evening Primrose Oil ◽  
Pharmaceutical Dosage Form ◽  
Evening Primrose ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

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.

scholarly journals DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF LAMIVUDINE IN TABLET DOSAGE FORM

2017 ◽  
Vol 9 (6) ◽  
pp. 86
Author(s):  
Kalpesh V. Sonar ◽  
Prabodh Sapkale ◽  
Anil Jadhav ◽  
Tushar Deshmukh ◽  
Swapnil Patil ◽  
...  
Keyword(s):  
Quality Control ◽  
Absorption Spectrum ◽  
Melting Point ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Beer’S Law ◽  
Solubility Studies ◽  
Development And Validation ◽  
Tablet Dosage

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lamivudine in tablet dosage form.Methods: The drug is freely soluble in analytical grade water. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer’s law and showed a good correlation of concentration with absorption which reflects in linearity. The UV spectroscopic method was developed for estimation of lamivudine in tablet dosage form and also validated as per ICH guidelines.Results: The drug is freely soluble in analytical grade water, slightly soluble in methanol and practically insoluble in acetone. So, the analytical grade water is used as a diluent in the method. The melting point of lamivudine was found to be 160-161˚C (uncorrected). It showed absorption maxima 268 nm in analytical grade water. On the basis of the absorption spectrum, the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of the analysis were validated by recovery studies. The recovery was found to be 98.7, 101 and 99.2% for three levels respectively. The % RSD for precision was found to be 0.62%.Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lamivudine in tablet dosage form. The method could be considered for the determination of Lamivudine in quality control laboratories.

scholarly journals Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Hesperidin and Diosmin in the Pharmaceutical Dosage Form

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Doddi Srilatha ◽  
Mahesh Nasare ◽  
Borra Nagasandhya ◽  
Valluri Prasad ◽  
Prakash Diwan
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Cost Effective ◽  
Simultaneous Estimation ◽  
Good Reproducibility ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Tool ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Control Tool

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.

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
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Difference Spectrum ◽  
Basic Medium ◽  
Difference Spectra ◽  
Pharmaceutical Dosage Form ◽  
Highly Sensitive ◽  
The Difference ◽  
Tablet Dosage

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.

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