Development Of Spectrophotometric Method Research Articles

Spectrophotometric Determination of Losartan Potassium and Hydrochlorothiazide in tablets by Wavelet Transform Approach

A precise, rapid and simple spectrophotometric method development with continuous wavelet transform technique was described in this paper for the simultaneous determination of losartan potassium and hydrochlorothiazide in tablets. The continuous wavelet transform approach based on the application of Symlets5-CWT. If the original UV spectra of losartan potassium and hydrochlorothiazide are examined, it is seen that the spectra of these two substances strongly overlap. With the developed Symlets5-CWT method, the analysis was carried out successfully without any pre-separation process. The calibration equations were obtained at 247.7 nm for the losartan potassium determination and at 259.1 nm for the hydrochlorothiazide determination, respectively. The developed methods were tested in terms of validity and applicability.

Development and Validation of UV-Visible Spectrophotometric Method for Estimation of Tacrolimus in Bulk and Pharmaceutical Nanoparticles

A UV-visible spectrophotometric method for quantifying tacrolimus in nanoparticles has been developed and validated, and it is accurate, simple, reproducible, and affordable. For drug analysis, optimal conditions have been identified. 291 nm was discovered to be the maximum wavelength (max). In the range of 0.2-1.8 mg/ml, the response was linear (r2 = 0.9989). The intra- and inter-day relative standard deviations for precision studies were found to be less than 2%, indicating that the procedure is precise.

Development of spectrophotometric method for analysis of mercaptopurine and dimercaprol for use in quality control and monitoring water pollution

In the present work, spectrophotometric method was developed for analysis of mercaptopurine and dimercaprol to be applied in quality control and monitoring water pollution. These drugs are used for the treatment of cancer and heavy metal poisoning respectively. Both mercaptopurine and dimercaprol react with colourless anhydrous manganese (II) acetate in DMSO to form soluble brown coloured complexes which showed λmax at 350 nm and 360nm during spectrophotometric analysis. This newly developed method was successfully applied for analysis of commercial drugs and spiked water. The recovery of these drugs from commercial formulations and spiked water samples was in the range between 98.0-99.7% with RSDs in the range 0.56-1.50% that indicated high degree of accuracy and precision of the method.

Development and Validation of Difference Spectrophotometric Method for Simultaneous Estimation of Rosuvastatin Calcium and Aspirin in Marketed Formulation

Objective: To develop and validate a simple Vierordt method for the simultaneous estimation of rosuvastatin calcium (RSV ca) and aspirin (ASP) in fixed dose combination capsules by difference spectrophotometry technique in the UV region. Difference spectrophotometry is based on the utilization of difference absorption spectra corresponding to the same compound obtained at two different pH values. 
 Methodology: The difference in spectral characteristics for the two drugs was observed in 0.01N acetic acid and 0.01N NaOH. The simultaneous equations were developed using difference absorbance and absorptivity values of the two drugs measured and calculated at 243.2nm and 297nm for RSV ca and ASP respectively.
 Results: Two drugs have shown very good linearity in the concentration range of 10-100µg/ml. The methods were validated as per ICH guidelines for the limit of detection, the limit of quantification, accuracy, and precision, which were found to be within the acceptable limits. The validated method was successfully applied for the analysis of rosuvastatin calcium and aspirin in fixed dose combination capsules.
 Conclusion: Because this approach is simple and does not require a particular programme, it can be used as a substitute for LC methods in quality control laboratories that lack the necessary equipment for those techniques.
 
 

UV Spectrophotometric Method Development and Validation of Lignocaine Hydrochloride in Bulk and Semisolid Dosage Form

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.

A Combine Spectrophotometric and Chromatographic Method Development and Validation of Levetiracetam Bulk And Tablet Dosage Form

Objective: Objective of the present analytical research work was to develop and validate Spectrophotometric method and High Performance Liquid Chromatographic method (HPLC Method) for the Levetiracetam bulk and tablet dosage form
 Methods: A spectrophotometric method and a HPLC method have been developed and validated for estimation of Levetiracetam in bulk.
 Method A (UV SPECTROMETRY Method): Methanol was used for the preparation of stock and working standard solutions of the drugs. 400-200nm UV range was used to scanned standard solutions of drugs using UV spectrophotometer. The λmax of Levetiracetam was found to be 220 nm.
 Method B (HPLC Method): The HPLC method for Levetiracetam was developed using cosmosil C18 (4.6 mm x 250 mm, particle size: 5 μm), as stationary particle, isocratic mode. Methanol: ACN: Water (60:20:20) pH3 as a mobile phase. The mobile phase was maintained at a flow rate of 1 ml / min and the detection was carried out at 220 nm. Both the methods were validated according to the ICH guidelines.
 Results: Levetiracetam was found to be linear in the concentration range of 10-50 µg/ml for spectrophotometric and HPLC method. Retention time was found to be 4.5 min for Levetiracetam.
 Interpretation and Conclusion: Results of validation study were found to be satisfactory. So, the methods can be successfully applied for the routine analysis of Levetiracetam.

UV Spectrophotometric Method Development and Validation of Esomeprazole in Bulk and Pharmaceutical Dosage Forms

The work discusses method development and validation. An uncomplicated, accurate, and straightforward method was developed for the drug Esomeprazole in bulk as well as Pharmaceutical dosage form. NaOH was used as the solvent. The maximum wavelength (ʎ max) for Esomeprazole was found to be 305nm. The validation was performed as per International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for Accuracy linearity, precision, Limit of Detection (LOD) and Limit of Quantification (LOQ). Esomeprazole's recovery percentage (%) was 100.20%, respectively. Linearity for Esomeprazole was observed between 5-25µg/ml, respectively. Regression equation y=0.0407x-0.0122, regression coefficient (r²) is 0.9963 for Esomeprazole. Inter day and intraday precision were checked, % relative standard deviation values were less than 2. The regression equations were used to derive the Limit of Detection (LOD) and Limit of Quantification (LOQ) values. LOD value was found to be 0.734 µg/mL and LOQ value was 2.224 µg/mL for Esomeprazole. The assay of the marketed formulation was performed, which was between 98-102%. So the method developed was simple and economical that can be adopted for routine tests.

Development and Validation of UV-Vis Spectrophotometric Method for Estimation of Black Seeds and Peppermint Oil in Emulsion

The purpose of the study was to develop and validate UV-Vis spectrophotometric method for estimation of black seed oil (BSO) and peppermint oil (PO). Emulsions were prepared using alginate (2.0 %) w/v as water phase and lecithin (3.0 %) w/v by incorporating BSO and PO oil separately. A good linearity result was recorded with R2 value at 0.9990 within the concentration range of 5.0-50.0 mg/ml for both oils. Moreover, the recovery percentage of accuracy for BSO was from 102.03 ± 0.16 % to 99.67 ± 1.53 % and 101.29 ± 1.94 % to 98.73 ± 1.19 % for PO, which suggests that the method was accurate and precise. The method was precise, as the largest % Relative Standard Deviation ( % RSD) value was 1.77 in intraday and 1.99 in interday for BSO, whereas 1.94 in intraday and 1.96 in interday for PO. The Detection Limit (DL) (0.469 mg/ml) and Quantification Limit (QL) (1.408 mg/ml) for BSO, and DL (0.709 mg/ml) and QL (2.127 mg/ml) for PO were measured. Based on this developed method, the % Encapsulation Efficiency (EE %) of optimized formulation was obtained 89.06 ± 0.39 % (n=3). This protocol may be used for estimation of EE % analysis of new drug formulation in pharmaceutical research and development and quality control analysis. Abbreviations: BSO: Black Seeds Oil; TQ: Thymoquinone; PO: Peppermint Oil; PBS: Phosphate Buffer Saline; N. sativa: Nigella sativa; Neem Seed Oil: NSO; DL: Detection Limit; QL: Quantification Limit; RSD: Relative Standard Deviation; SD: Standard Deviation; ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; HPLC: High-Performance liquid Chromatography; GC-MS: Gas chromatography-mass spectrometry; EE: Encapsulation Efficiency; PBS: Phosphate Buffer Saline; EDTA: Ethylenediamine tetraacetic acid; w/v: Weight/Volume; T80: Tween 80.

Increasing the Robustness of Biopharmaceutical Precipitation Assays – Part I: Derivative UV Spectrophotometric Method Development for in-line Measurements

In vitro precipitation assays are often applied to support drug and formulation development. Current methods applied to quantify the amount of dissolved drug, in particular (U)HPLC, require time-consuming sample preparation. Furthermore, small precipitates formed during the nucleation phase may not be removed quantitatively by filtration or centrifugation of the sample. Given the drawbacks of standard (U)HPLC analyses during the application in transfer experiments, it was the aim of this work to develop a robust and simple to implement in-line UV spectrophotometric method which accurately reflects the precipitation profile obtained from in vitro transfer assays. Based on the three model compounds cinnarizine, dipyridamole, and ketoconazole, the manuscript describes the development of a design of experiments (DoE) based approach to develop derivative UV spectrophotometric methods accounting for the change in media composition over time due to the dilution of simulated intestinal with simulated gastric fluid. An R script was developed which automatically identifies suitable wavelengths for in-line measurements. As an outcome of this study, a fast, robust, accurate, and specific derivative UV spectrophotometric methodology for measuring the concentration of dissolved drugs in in vitro transfer experiments was successfully developed. This method can flexibly be applied to multi-compartmental precipitation assays.

To Estimate the Label claim of tablet in their combination by simultaneous estimation using UV-Visible Spectrophotometric method

Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.

UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation

UV-Spectrophotometric method has been developed and validated for quantitative estimation of dasatinib in bulk and pharmaceutical formulation. Dasatinib is soluble in acetonitrile, so it was used as solvent. Dasatinib was dissolved in acetonitrile and resulting solution was scanned in UV range (200-400nm). The λmax was found to be 315nm. Beers law is valid in concentration range of 5-25µg/ml. The developed method was validated for linearity, accuracy, precision, robustness; LOD and LOQ. Linearity was obtained in the range of 5-25µg/ml with correlation coefficient 0.9992. LOD and LOQ were found to be 0.908µg/ml and 2.752µg/ml respectively. The method showed good reproducibility and recovery so; proposed method can be applied for routine analysis of dasatinib in bulk and pharmaceutical formulation.

UV Spectrophotometric Method Development and Validation of Carbimazole in Bulk and Tablet Dosage form

Objective: A new, simple, sensitive, precise, reproducible UV visible spectrophotometric method was developed for the estimation of Carbimazole in Tablet dosage form. Methods: The UV spectrum of Carbimazole in methanol and distilled water (30:70) showed λ max at 289.6nm. Beer’s law is valid in the concentration range of 10-50µg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-50µg/ml with the regression equation y = 0.0232x + 0.0466, and regression coefficient i.e, r2= 0.9992 moreover, the method was found to be highly sensitive with LOD (1.818µg/ml) and LOQ (5.509µg/ml). Conclusion: From the results it can be concluded that the given method can be successfully applied for assay of Carbimazole in Tablet dosage form.

Development and validation of spectrophotometric method for quantitative determination of carvedilol in tablets

INTRODUCTION: Carvedilol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. AIM: The aim of this article is to develop a spectrophotometric method for the quantitative determination of carvedilol with diazonium salts, establish optimal conditions for the quantitative determination of carvedilol in drugs, and validate the developed methodology. MATERIALS AND METHODS: All studies were conducted on the basis of the experimental pharmaceutical research department of the scientific medical laboratory center (NMLC) of the Zaporozhye State Medical University. Reagents and solvents: 6.25 mg carvedilol tablets (PRANAPHARMJSC, Samara, series 20717), 12.5 mg Carvedilol Canon tablets (Canonpharma Production CJSC, Russia, series 060517), 25 mg Talliton tablets (EGIS Pharmaceuticals PLC, Hungary, series 473D0617), 25 mg Carvedilol-KV tablets (OJSC Kyiv Vitamin Plant, Kyiv, Ukraine, series EF 411017), diazol red 2G (NVF Sinbias), acetone, methanol, ethanol, isopropanol, water. Analytical equipment: SPECORD-200spectrophotometer (Analytic Jena AG, Germany), ULAB S131UV spectrophotometer, RADWAG XA 210.4Y electronic laboratory scales, Sonorex Digitec DT100H ultrasonic bath. RESULTS: The technique of spectrophotometric determination of the quantitative content of carvedilol based on its reaction with red diazole in water-methanol medium has been developed. The 1:1 stoichiometric ratios of the reactive components were obtained by the methods of continuous changes and the saturation method. CONCLUSION: A spectrophotometric method of analysis for the quantitative determination of carvedilol in tablets has been developed. The method is simple, fast, accurate, and reliable. This has been proven by verification characteristics (linearity, precision, correctness and sustainability). The developed methodology is correct and can be used in the chemical and pharmaceutical industries.

Разработка спектрофотометрической методики количественного определения нового биологически активного производного имидазола

Разработка спектрофотометрической методики количественного определения нового биологически активного производного имидазола

UV Spectrophotometric Method Development and Validation of Luliconazole in Bulk and Formulation

Objective: A new, simple, economical, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the estimation of luliconazole in pure form and pharmaceutical formulation as per ICH guidelines. Method: A UV spectrophotometric method has been developed using methanol and water as solvent to determine the luliconazole in bulk and pharmaceutical dosage formulation. The λmax of luliconazole in methanol and water was found to be 297nm. Results: The drug was proved linear in the range of 3-15µg/ml and exhibited good correlation coefficient (R2= 0.9993) and excellent mean recovery (98-99%). The % RSD for intra-day and inter-day precision was found to be 1.051288 and 1.138658 respectively. The LOD and LOQ of Luliconazole was found to be 1.1168µg/ml and 3.3845µg/ml respectively. This method was successfully applied to luliconazole content in marketed brands and results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of luliconazole in bulks as well as in commercial formulations.

Development of derivative spectrophotometric method for simultaneous determination of pyrazinamide and rifampicin in cubosome formulation

The ultraviolet spectrophotometry analysis for quantitative assay of drugs is a method accurate, sensitive, selective and reproductive with the advantage of being a simple and less expensive method. In this study, a derivative ultraviolet spectrophotometric method was developed for simultaneous determination of pyrazinamide (PYZ) and rifampicin (RIF). The spectrophotometric method was evaluated according to validation guidelines for specificity, linearity, limits of detection and quantification, precision, accuracy and robustness. The first-derivative spectra were obtained and by the zerocrossing point, the wavelength 247 nm and 365 nm were selected for PYZ and RIF quantification, respectively. No interference from cubosome excipients was detected in the proposed method. The results demonstrated linearity in a range of 4.0 – 12.0 µg/mL with an adequate correlation coefficient for both drugs. The intra and inter-day precision results (RSD < 5%) indicated the reproducibility of the method. The accuracy data showed satisfactory results (RSD < 5%) from recovery test. In addition, the robustness results showed that the PYZ and RIF content were unaffected by the solvent alteration of methanol to methanol:water (99:1, v/v). The derivative ultraviolet spectrophotometric method proved to be an excellent strategy for simultaneous determination of PYZ and RIF.

Development and Validation of UV-Visible Spectrophotometric method for the Estimation of Curcumin and Tetrahydrocurcumin in Simulated Intestinal Fluid

Background: Due to solubility issues of curcumin and tetrahydrocurcumin, there is a need for the development of a UV-Visible spectrophotometric method that can estimate the drug release precisely and accurately. The addition of surfactant in the dissolution medium in low concentration achieved bio-comparable surface activity and can be used to estimate the drug release from formulations by avoiding sink conditions. Objective: The purpose of the present investigation was to develop a simple and précise UV-Visible spectrophotometric method for the determination of curcumin and tetrahydrocurcumin after oral administration. Method: A UV-Visible spectrophotometric method was developed using an appropriate solvent system for the estimation of curcumin and tetrahydrocurcumin. The solvent system having simulated intestinal fluid and particular concentration of surfactant was selected and further validated according to guidelines of the international conference on harmonization (ICH), the analytical parameter like linearity, precision and accuracy, etc. were studied. Results: Simulated intestinal fluid pH 7.4 with tween 80 at 1 % concentration satisfied all the conditions relative to peak quality at the stated wavelength for curcumin and intestinal fluid pH 7.4 with tween 80 at 0.5% concentration satisfied all the conditions relative to Peak quality at the stated wavelength for tetrahydrocurcumin. The developed methods were found within the range of all the validation parameters. Conclusion: The proposed method was found to be very simple and precise and can be used for routine quantitative analysis of curcumin and tetrahydrocurcumin.

UV Spectrophotometric Method Development and Validation of Darunavir in bulk and Solid Dosage Form

Objective: A new, simple, sensitive, precise, reproducible UV visible spectrophotometric method was developed for the determination of Darunavir in Tablet dosage form with¬¬¬ 0.1N HCl. Method: The method is based on the formation of a colorless complex. The UV spectrum of Darunavir in 0.1N HCl showed maximum wavelength at 298nm. Beer’s law is valid in the concentration range of 10-60µg/ml. this method was validated for linearity, accuracy, precision, assay, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-60µg/ml with the regression equation y=0.0113x+0.0098, and regression coefficient i.e. r2=0.9992 moreover, the method was found to be highly sensitive with LOD (1.85µg/ml) and LOQ (5.62µg/ml). Conclusion: Based on the results the proposed method can be successfully applied for the assay of Darunavir in various tablet dosage forms.

Development and Validation of Direct Spectrophotometric Method for the Estimation of Glimepiride

Aims: To develop simple, sensitive and direct spectrophotometric methods for the estimation of widely prescribed antidiabetic hypoglycemic agent Glimepiride in pure and pharmaceutical dosage form.
 Place and duration of study: Research Centre of Taywade Group of Institution Koradi, Nagpur affiliated to Rashtrasant Tukadoji Maharaj Nagpur University Nagpur between June 2020 and March 2021.
 Methodology: Two spectrophotometric methods were developed based on ion-pair formation of drug with Cresol Red dye (Method A) and Bromophenol Blue dye (Method B) in methanol and chloroform. The possible reaction mechanism was proposed with evaluation of statistical parameters. The methods were validated for its application to determine Glimepiride in bulk as well as in pharmaceutical formulations
 Results: The Beer's law was found linear in the range 10 - 60 µgml-1 at 450 nm for method A and 2 - 20 µgml-1 at 578 nm for method B, respectively. The linear regression equation obtained by applying least square regression analysis for Glimepiride were found to be Absorbance = 0.0136 x Concentration in µgml-1 + 0.028; R2 = 0.9965 for method A and Absorbance = 0.0428x Concentration in µgml-1 +0.0722; R2 = 0.9949 for method B. The Sandell's sensitivity was found to be 0.0696 and 0.0177 for method A and B respectively. The apparent molar absorptivity calculated to be for both methods were 6.6724 x103 and 2.0999 x104 l mol-1 cm-1.
 Conclusion: Two direct spectrophotometric methods for determination of Glimepiride have been developed successfully and validated for sensitivity, accuracy, precision, repeatability and robustness as per ICH guidelines. The developed methods are suitable for the routine estimation of Glimepiride in pure and dosage form.

Development of rapid and simple spectrophotometric method for the simultaneous determination of anti-parkinson drugs in combined dosage form using continuous wavelet transform and radial basis function neural network

In this study, simultaneous measurements of levodopa (LD), carbidopa (CD), and entacapone (ENT) as anti-parkinson drugs were investigated in synthetic mixtures and Staparkin tablet by continuous wavelet transform (CWT) and radial basis function neural network (RBF-NN) along with spectrophotometric method. In the CWT method, based on the best zero crossing point and R squared (R2) related to the calibration solutions, the Symlet with second order (Sym2), the Daubechies with second order (Db2), and Gaussian as wavelet families were selected for LD, CD, and ENT, respectively. Limit of detection (LOD) and limit of quantification (LOQ) of standard samples for LD, CD, and ENT were 0.0076, 0.159, 0.1519 and 0.0055, 0.0148, 0.3854 μg mL−1, respectively. Also, the average recovery of synthetic mixtures, containing LD, CD, and ENT was obtained 100.23%, 100.01%, and 99.88%, respectively. In the RBF-NN model, root mean square error (RMSE) of 1.14 × 10−27, 2.94 × 10−14, and 8.675 × 10−15 were found for LD, CD, and ENT, respectively. The comparison of proposefd methods with each other was performed on a commercial tablet sample through analysis of variance (ANOVA) test at 95% confidence level. In addition, the standard addition technique was applied to evaluate the performance of these methods in complex matrix. Due to the fast, simple, inexpensive, accurate, as well as without need separation steps, the proposed method can compete with high-performance liquid chromatography (HPLC).