Development Of Spectrophotometric Method Research Articles

Environmental Friendly Analysis: Development and Validation of UV-Visible Spectrophotometric Method for Methotrexate Quantification in Marketed Dosage Forms and Nano Transethosomes

Environmental Friendly Analysis: Development and Validation of UV-Visible Spectrophotometric Method for Methotrexate Quantification in Marketed Dosage Forms and Nano Transethosomes

Development of Spectrophotometric Method for the Quantitative Determination of Betamethasone 17- Valerate in Creams

A simple spectrophotometric technique has been developed and validated for determination of betamethasone 17-valerate in pharmaceutical formulations. The method is based on cream dissolution in absolute ethanol and assaying spectrophotometrically at 240nm. The amount of betamethasone 17-valerate in cream was determined as 101.6 ± 0.0037 % w/w. The method validation demonstrated linearity for concentration range of 0.006mg/ml to 0.0014mg/ml (R2=0.9995). The method is simple and accurate and has successfully been employed in the analysis of some of Tripharm pharmaceutical formulations.

Spectrophotometric method development and validation for methamphetamine in human urine

Spectrophotometric method development and validation for methamphetamine in human urine

A Novel Uv Spectrophotometric Method Development and Validation of Dalfampridine in Bulk and Pharmaceutical Dosage Form

Simple, precise and accurate zero order derivative spectroscopic method has been developed and validated for the estimation of dalfampridine in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 262nm in 0.1M HCL and obeys Beer’s law in the concentration range of 0.5-3.0µg/ml. The linearity study was carried out and regression coefficient was found to be 0.9976 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.66% -101.56%. The LOD and LOQ were found to be 0.0360 and 0.109µg/ml. The % relative standard deviation were found to be less than 2. According to ICH guidelines the technique has been validated for linearity, precision, accuracy, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for routine quantification of Dalfampridine in bulk and pharmaceutical dosage form.

A NOVEL SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF RANOLAZINE IN BULK DRUG AND IT’S FORMULATION

The simple, rapid, precise, accurate, robust and economical analytical method has been developed for estimation of Ranolazine in bulk and pharmaceutical dosage form. This study describes the validation of an UV Spectrophotometric method for quantitative determination of Ranolazine in pharmaceutical dosage form using acetate buffer (pH 4.4) as solvent. The maximum absorbance was found at 272 nm. The Linearity was found to be in range of 5 to 40µg/ml. The %RSD for Intraday and Interday precision studies was found to be 0.793 and 0.793 respectively. The % assay was found to be 99.6%±0.05. The average % recovery of ranoalazine was found to be in between 98.5-101.7%. LOD and LOQ was found to be 0.58 µg/ml and 1.75 µg/ml respectively. The results suggest that this method can be employed for routine analysis of Ranolazine in bulk and commercial pharmaceutical formulations. KEY WORDS: Ranolazine, UV Spectrophotometric Method, Method Development and Method Validation.

Development and Validation of UV-VIS Spectrophotometric Method for Estimation of Methylprednisolone from Dissolution Media

A simple, accurate UV-Spectrophotometric method has been developed using a dissolution media, 0.1% Tween 20 as a solvent to determine the Methylprednisolone. At a predetermined λmax of 245 nm, method was proved linear in the range of 5- 40 μg/ml with good correlation coefficient (R2= 0.998) and excellent recovery (between 98 and 101%). This method was successfully applied to the determination of methylprednisolone from dissolution media, 0.1% Tween 20 solution. This method can be employed for the dissolution study of methylprednisolone in injectable suspension.

Development And Validation of UV-VIS Spectrophotometric Method for Determination of Triamcinolone from Dissolution Media

A simple, accurate UV-VIS Spectrophotometric method has been developed using a dissolution media, Tween 20 (0.15%) as a solvent to determine the Triamcinolone. At predetermined λmax of 240 nm, method was proved linear in the range of 10-50 µg/ml with good correlation coefficient (R2= 0.998) and excellent recovery (between 98 and 101%). This method was successfully applied to the determination of Triamcinolone from dissolution media, 0.15% Tween 20 aqueous solution. This method can be employed for the dissolution study of Triamcinolone in injectable suspension.

Spectrophotometric Method Development and Validation for the Estimation of Trelagliptin Succinate in Bulk and Pharmaceutical Dosage Form

A Simple, precise and sensitive ultraviolet spectrophotometric method was developed for the estimation of Trelagliptin succinate in bulk and pharmaceutical dosage form, method was run through LABINDIA UV-Visible spectrophotometer-3200 with solvent of acetonitrile was used. In this method working wavelength was selected at 276 nm. The developed method was validated as per the international conference on harmonization (ICH Q2(R1)) guidelines. The drug was obeying Beer-Lambert’s law revealed good correlation in the concentration range of 10 - 60 µg/ml with correlation coefficient (r2) of 0.9993. The validity of the proposed method was assessed by applying the standard addition technique where the percentage recovery of the added standard was found to be 99.97 % for Trelagliptin succinate. The absorbance was found to be 0.0365 - 0.0506 with %RSD for both inter-day precision & intraday precision. The limit of detection and quantification were calculated and was found to be 0.0563 µg/mL and 0.1689 µg/mL respectively. The developed method was successfully applied to the determination of Trelagliptin in commercially available dosage form with percentage assay of 98.52. The proposed method is recommended for routine analysis of Trelagliptin in bulk and dosage forms in quality control testing laboratories. Since it is rapid, simple, accurate and sensitive.

Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form

Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form

UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation

The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes.
 Keywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines.

Formation and characterization of charge transfer complex between alectinib and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone: Application to development of microwell spectrophotometric method

Alectinib (ALC) is a novel highly selective anaplastic lymphoma kinase (ALK) inhibitor that is effective in the treatment of patients with advanced ALK-positive non-small cell lung cancer and lymphomas. This study, describes, for the first time, the formation of a charge transfer complex (CTC) between ALC with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ). The CTC was characterized using different spectrophotometric and computational techniques. UV–visible spectrophotometry ascertained the formation of the CTC in methanol via the formation of a new broad absorption band with a maximum absorption peak (λmax) at 505 nm. The molar absorptivity (ε) of the complex was 2.72 × 103 L mol−1 cm−1 and its band gap energy was 1.94 eV. The stoichiometric ratio of ALC:DDQ was found to be 1:1. The association constant of the complex was 9.6 × 102 L mol−1, and its standard free energy was −16.98 J mol−1. Computational calculations were conducted using different calculation tools. The computed geometrical parameters, specifically bond lengths, exhibited variations in the CTC compared to the individual reactants (ALC and DDQ). The Mulliken atomic charge analysis indicated increased values for DDQ (the acceptor) and decreased values for ALC (the donor) in the CTC, confirming the formation of a CTC. The reaction was employed as a basis for a novel microwell spectrophotometric method for the quantification of ALC in its bulk form, capsule content, and uniformity testing. This greenness and high throughput of the method was documented. The method represents a valuable tool for routine use in quality control laboratories for analysis of ALC's bulk form and capsules.

Development and validation of spectrophotometric method and paper-based microfluidic devices for the quantitative determination of Amoxicillin in pure form and pharmaceutical formulations

There is a growing need for easy-to-use, low cost and portable quantitative assays to determine active pharmaceutical ingredients in the pharmaceutical industry. Here, we developed a batch spectrophotometric method and a method employing a paper-based microfluidic device for the estimation of Amoxicillin (AMX) in pure solution and pharmaceutical preparations. The detection depends on the coupling reaction of Amoxicillin with diazotized sulfadimidine (DSDM) in an alkaline medium. The yellow azo dye reaction product was measured at λmax 425 nm and linearity was observed from 2 to 30 mg L−1 with a detection limit of 0.32 mg L−1 and a quantification limit of 1.2 mg L−1 was found. The reaction was then transferred onto the paper-based microfluidic device and a plateau change in color intensity was found above 10 mg L−1. Thus, the paper-based microfluidic device can be applied for the semi-quantitative determination of Amoxicillin in pure solution and commercial pharmaceutical products for rapid screening.

Development and Validation of FT-IR Spectrophotometric Method for Simultaneous Estimation of Clonidine Hydrochloride and Chlorthalidone in Pharmaceutical Synthetic Mixture

A precise, simple, cost effective, accurate, eco-friendly and validated fourier transform infrared spectroscopy method has been developed for the simultaneous estimation of Clonidine Hydrochloride and Chlorthalidone in pharmaceutical synthetic mixture. The developed method involves measurement of spectral wavenumber of the infrared band corresponding to (–C=N) from 1658.78 cm-1 for Clonidine Hydrochloride and (-S=O) group from 1346.31 cm-1 for Chlorthalidone. Over the range of 1.5–3% w/w for Clonidine hydrochloride and 15–90% w/w for Chlorthalidone, the method was found to be linear. It has correlation coefficient (r2) of 0.999 for Clonidine hydrochloride and 0.994 for Chlorthalidone. According to ICH guidelines, in terms of accuracy, linearity, limit of detection and limit of quantitation, precision, the developed method was validated. In addition to this, degradation behaviours of Clonidine Hydrochloride and Chlorthalidone were studied by subjecting them to sunlight, photolytic and thermal degradation.

UV Spectrophotometric Method Development and Validation for Simultaneous Quantification of Clidinium Bromide and Chlordiazepoxide Hydrochloride in Dosage Form

UV Spectrophotometric Method Development and Validation for Simultaneous Quantification of Clidinium Bromide and Chlordiazepoxide Hydrochloride in Dosage Form

Development of Spectrophotometric Method for The Determination of Mesalazine as Pure Form and in Tablets

This method involves development of a highly sensitive spectrophotometric procedure to estimate mesalazine as pure substance and in the tablets. This particular procedure was focused on the diazotization of mesalazine with an excess quantity of sodium nitrite (NaNO2) in an acid medium using HCl solution to produce a corresponding diazonium compound which reacts with 8-hydroxyquinoline reagent in an alkaline solution of NaOH to yield read-orange azo dye which is soluble in water and showed maximum absorption peak at the wavelength of 500 nm against the blank solution. The calibration graph was linear and compatible to Beer's law over the concentration range from 0.25 to 12.5 μg/ml with an exceptional determination coefficient (R2= 0.9994) and apparent molar absorptivity 2.88 × 104 L.mol-1cm-1. The limits of detection (LOD) and quantitation (LOQ) were premeditated and found to be 0.2023 and 0.6524 μg/ml, correspondingly. A relative error percent (accuracy) and the relative standard deviation (RSD%) was also calculated and found to be in the range -3.84% - 2.70%, and 0.17% - 1.94%, correspondingly. No interferences were observed from other ingredients that may be exist in the tablets. The stoichiometry of the resulting azo dye has been examined and the experimental results revealed that the mole ratio of mesalazine to 8-hydroxyquinoline is 1:1. The advised procedure was successfully applied for the determination of mesalazine in its pharmaceutical form (tablets).

Development of Visible Spectrophotometric Method and its Validation for Dolutegravir in Tablet Dosage Form

Objective: There are several methods for analyzing the same, however, they are time-consuming and costly. We created a new spectrophotometric method for determining Dolutegravir (DLT) in tablet dosage forms that is simple, accurate, and precise. We developed and validated a simple, accurate, and precise colorimetric method for the quantitative analysis of Dolutegravir in bulk and dosage form by ICH recommendations in this study. Methodology: There are several methods for analyzing the same, however, they are time-consuming and costly. We created a new spectrophotometric method for determining Dolutegravir (DLT) in tablet dosage forms that is simple, accurate, and precise. In methanol, the initial stock solution of Dolutegravir was prepared. The method is based on the formation of a blue color chromogen complex from Dolutegravir oxidation-reduction with Ferric chloride in the presence of potassium ferricyanide. Result: The color complex was measured at 710nm. Beers law was observedin the concentration range of 3.5-6.5μg/ml witha coefficient of correlation (R2) was 0.998. The system suitability criteria were found to be within the limits. The LOD and LOQ were found to be 0.91 and 2.47, indicating that the method is sensitive. Conclusion: The relative standard deviation (RSD) and percent recovery values were found to be satisfactory, indicating that the proposed method is suitable, accurate, and precise and that it can be used in routine analysis of Dolutegravir in tablet dosage forms, with relatively low-cost solvents.

Spectrophotometric Determination of Ampicillin Using Chromogenic Reagents (MBTH and PDAC) and their Application in Pharmaceutical Formulations

The present work highlights the spectrophotometric method development and validation for the assay of ampicillin, a broad-spectrum β-lactam antibiotic. Two methods have been proposed by employing popular chromogenic reagents viz 3-methyl 2-benzothiazolinone hydrazone (MBTH) and para dimethyl amino cinnamaldehyde (PDAC). Method A involves the coupling of ampicillin with MBTH in the presence of ferric chloride through the oxidative mechanism, resulting in the formation of green coloured solution with a maximum absorption peak at 620 nm. In method B, the condensation reaction of ampicillin with an acidic solution of PDAC gave a coloured reddish-brown complex, showing a maximum absorption peak at 514nm. Linear calibration curve for MBTH and PDAC has been obtained while obeying Beer’s law in the concentration range of 0.5 -1 and 5-15 μg/ml having a good correlation coefficient of 0.9985 and 0.9974 respectively. The sensitivity of the submitted methods was found to be more than the reported methods. Both methods were successfully applied to a pharmaceutical formulation for quantifying the ampicillin effectively. Therefore, the developed spectrophotometric methods can serve as a good analytical assay procedure for ampicillin to undergo quality control in pharmaceutical setups.

Green Analytical UV-VIS Spectrophotometric Method Development of Valsartan by using Hydrotropic agent

The aim of the present research was to increase the solubility of valsartan in water by hydrotropic solubilisation. Hydrotopes are surface active, highly water soluble organic salt, which imparts solubility to insoluble or sparingly soluble organic compounds in water, which is when present at higher concentration. An analytical method was developed for the estimation of valsartan by UV-VIS spectrophotometry. Solvent 1% w/v sodium acetate solution was utilized and 247.2nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 4-48mcg/ml (microgram/ml). The accuracy was found within acceptable limit with nominal conc102.68 – 105.10 %; and the precision study was shown acceptable data as %SD varied from 1.88573 to 3.97617. The stability of the method was studied by minor variation in the wavelength, scan speed and acid, alkali and peroxide stress degradation study. The developed method is rigid, robust and efficient for the estimation of VST from the dosage form. The effort was made to develop green or eco-friendly analytical method utilising hydrotropic solvent for water insoluble drug valsartan.

Spectrophotometric Method Development for Estimation of Multicomponent Antidiabetic Drugs in Bulk and Solid Dosage Form

Abstract: The aim of the present study was the development and validation of a simple, precise and accurate UVspectrophotometric method for the estimation of metformin (MET), voglibose (VOG) and pioglitazone (PIO) in bulk and tablet dosage form using methAanol as solvent. The method was proposed in the present work, the maximum absorbance was shown at 236nm for MET, 256nm for VOG and 268nm for PIO. The concentration range was 5-25, 0.2-1 and 2-10μg/mL with correlation coefficient 0.0998, 0.999 and 0.999 for MET, VOG and PIO respectively. The various parameters, such as linearity, system suitability, accuracy, precision, ruggedness, limit of detection and limit of quantification were studied as per ICH guidelines. Accuracy of the method was verified by performing recovery studies using simultaneous equation method and found to be 100.04-100.48% for MET, 98.70-99.70% for VOG and 98.67-100.27% for PIO indicates good accuracy of the method. Excellent mean recovery studies for precision, repeatability, ruggedness and sensitivity results showed that the method has been validated successfully, the results are also in accordance with the % RSD values obtained within specified limits. The proposed method was applied to the determination of MET, VOG and PIO, the mean % amount was found to be 100.21 (MET), 98.70 (VOG) & 101.28 (PIO) with % RSD values NMT 2.0% indicates the developed method was successfully applied for analysis of marketed formulation. The developed spectrophotometric method can be employed for routine analysis of MET, VOG and PIO in bulk and tablet formulation.

Improved UV-Visible Spectrophotometric Analytical Method Development and Validation for Precise, Efficient and Selective Quantification of Atorvastatin Calcium in Bulk Form

Introduction: The quantification of atorvastatin calcium in bulk form has been created using an Ultra Violet (UV) Spectrophotometric technique. Objective: In the present study, a novel UV-spectroscopic method for calcium quantification of atorvastatin in bulk form was developed and validated. Method: Various ratios of methanol and distilled water were investigated during the development of the analytical procedure; nevertheless it was found that the drug/actives was soluble in methanol: water (50:50). Scanning in the 200-400 nm range revealed that the detection wavelength (max) with 10 μg/ml was 246 nm. Result: According to the validation results, excipients in the pharmaceutical dosage form had no impact on the analysis. The average content percentages were 97.95±1.66 per cent and 98.42±0.91 per cent, respectively. The percentage Assay determination of the marketed pill was 99.340.3361%. The recovery percentages were 99.94±0.076 per cent and 99.98±0.079 per cent, respectively. Furthermore, robustness was discovered to be 99.76±0.367 per cent to 98.88±0.305 per cent. Conclusion: The method was evaluated for analytical solution stability, specificity, linearity, accuracy, range, precision, repeatability, and robustness. Statistics and specificity studies were used to validate the investigation's findings. This investigation demonstrated the method's applicability for routine atorvastatin calcium estimation in tablet and bulk dosage forms.