Validation Of UV Spectrophotometric Method Research Articles

Development And Validation of UV Spectrophotometric Method for The Estimation pf Amlodipine Besylate in Bulk and Dosage Form

A rapid, simple, accurate, and specific UV Spectrophotometric method has been developed for the determination of Amlodipine Besylate in bulk and dosage form. The spectrophotometric detection was carried out at an absorption maximum of 239 nm using dil. HCl as a solvent. The detector response for the Amlodipine Besylate was linear over the selected concentration range 4-20 µg/ml with a correlation coefficient of 0.999 and equation for the regression curve was found to be y= 0.109x + 0.006. These methods can be adopted in the routine assay analysis of Amlodipine Besylate API and pharmaceutical dosage form.

Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of some SGLT-2 and DPP-4 inhibitor in Bulk and Pharmaceutical Dosage Form

The result of pharmaceutical industry research for the new class and the new combination of drugs for the treatments of diabetes is the newly approved combination of Remogliflozin etabonate (RGE) and Teneligliptin Hydrobromide hydrate (TG). For the quality control of this formulation, the smart, reproducible and non-sophisticated spectroscopic techniques were developed by modification of UV spectra. The proposed methods exhibited Beer’s law in the range of 10 to 60µg/ml and 5 to 30µg/ml for RGE and TG correspondingly. The mean percentage recovery was found to be in the range of 98.60 to 101.55 for RGE and 99.87 to 100.21 for TG. Further, both analytes were quantified from the formulation using proposed spectroscopic methods with high accuracy. The suggested technique is simple, accurate and reproducible, hence could be used for regular quality control of formulation consisting of RGE and TG. The developed method can be used for analysis of stability samples and routing quality control evaluation in tablet formulation.

Bioanalytical Method Development and Validation of UV Spectrophotometric Method for Estimation of Sitagliptin in Urine sample

Bioanalytical Method Development and Validation of UV Spectrophotometric Method for Estimation of Sitagliptin in Urine sample

UV Spectrophotometric Method for Estimation of Voriconazole in Bulk Form

This study presents a validated UV spectrophotometric method for the precise estimation of voriconazole in bulk formulations. Voriconazole, an essential antifungal agent, demands accurate quantification for its pharmaceutical applications. The proposed method leverages the sensitivity of UV spectroscopy to determine voriconazole concentrations effectively.
 The method's validation adheres to regulatory guidelines, ensuring reliability and accuracy. Spectrophotometric analysis was performed within a specific wavelength range, demonstrating linearity, precision, accuracy, and robustness across different concentrations of voriconazole.
 Parameters such as specificity, sensitivity, and stability were evaluated to affirm the method's suitability for routine analysis.
 The results indicate the method's efficacy in quantifying voriconazole in bulk and semi-solid forms with high precision and sensitivity. This validated UV spectrophotometric method presents a valuable tool for pharmaceutical analysis, facilitating quality control and assurance in voriconazole formulations.
 Keywords: Voriconazole, UV spectrophotometry, Anti-fungal, semi-solid formulation, Beer’s Lambert’s law.

Development and validation of UV spectrophotometric method for estimation of naringenin in phytosomal formulation: interlaboratory comparison, capability, and statistical analysis.

The goal of the current work was to establish a simple, reproducible, and reliable UV spectrophotometric method for determining naringenin in phytosomal formulations. The solvent methanol was optimized and spectrophotometric analysis was carried out at 289nm. The proposed method was also validated for linearity, specificity, accuracy, precision, ruggedness, and robustness in accordance with the International Council for Harmonisation (ICH). With a correlation coefficient of 0.9982, the concentration of naringenin in the range of 2-14μg/ml follows Lambert-Beer rule. The accuracy ranged between 99.33 and 99.75%. The predicted percent recovery was found to be 99.48 ± 0.41. It was found that the limits of detection (LOD) and quantification were 0.54μg/ml and 1.66μg/ml, respectively. The normality of the data is accepted by the Shapiro-Wilk test (P = 0.9065) and Shapiro-Francia test (W = 0.9866). On the Bland-Altman plot, an acceptable repeatability coefficient was found. The remarkable inter-laboratory repeatability was proved by the Youden plot, which was also utilized to spot random and total errors. Levey-Jennings charts and other control diagrams have demonstrated that the method is statistically controlled. Greater values of Cp (1.03) and Cpk (0.83) were seen in the capability analysis, indicating that the method could analyze the samples reliably and consistently with minimum variation. The validation report demonstrated that the proposed method was appropriate for naringenin detection and analysis in phytosomal formulations, indicating that it can be employed for routine laboratory analysis as well.

Development and Validation of UV-Spectrophotometric Method Towards Determination of Ripasudil Hydrochloride Hydrate in Pure and Ophthalmic Formulation

Development and Validation of UV-Spectrophotometric Method Towards Determination of Ripasudil Hydrochloride Hydrate in Pure and Ophthalmic Formulation

New Validated UV Spectrophotometric Method for the Quantification of Bisoprolol Fumarate in its Pharmaceutical Dosage Form

New Validated UV Spectrophotometric Method for the Quantification of Bisoprolol Fumarate in its Pharmaceutical Dosage Form

Development and Validation of UV Spectrophotometric Method for Determination of Paracetamol in Chitosan Coated Alginate Beads and Dissolution Studies

Development and Validation of UV Spectrophotometric Method for Determination of Paracetamol in Chitosan Coated Alginate Beads and Dissolution Studies

Development and validation of UV spectrophotometric method for determination of chlorpropamide in bulk and formulation

The current work focuses on the development and validation of a UV spectrophotometric technique for determining chlorpropamide in bulk and formulation. According to ICH criteria, UV spectrophotometric method was validated for a number of parameters, including linearity, precision, accuracy, sensitivity, limit of detection (LOD), and limit of quantification (LOQ). The maximum wavelength of chlorpropamide was discovered to be 580 nm, and a colorimetric method was created for the quantitative estimation of colour and to quantify the absorbance of a particular wavelength of light by a particular solution. The maximal wavelength of chlorpropamide in the complex mixture was discovered to be 710 nm. The UV spectrophotometric technique and colorimetry are simple, sensitive, accurate, repeatable, and exact. Chlorpropamide in bulk can be determined effectively using the suggested method.

Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Dolutegravir Sodium and Rilpivirine Hydrochloride in Pure Bulk Form

A simple, specific, sensitive, rapid, precise, accurate and economical UV Spectrophotometric simultaneous equation method have been developed and validated for the routine estimation of Dolutegravir sodium and Rilpivirine Hydrochloride in bulk form. The Method A employs estimation of drugs by simultaneous equation method (SEM) using synthetic mixture of drugs. The absorption maxima of drugs were found to be at 259.20nm for Dolutegravir sodium and 305.80nm for Rilpivirine Hydrochloride. Both drugs followed the beer lamberts law in the range of 4-24µg/ml and 1-8µg/ml for DOL and RIL respectively. Methods are validated according to ICH guidelines and can be adopted for the routine analysis Dolutegravir sodium and Rilpivirine Hydrochloride in pure bulk form.

Development and validation of UV Spectrophotometric method for simultaneous estimation of Efonidipine hydrochloride ethanolate and Chlorthalidone in their synthetic mixture

Efonidipine Hydrochloride Ethanolate and Chlorthalidone is used in management of hypertension and under clinical phase 3 study. The development of quality control method is required for accurate analysis of both drugs. Two simple, precise and economical UV spectrophotometric methods have been developed for the simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Chlorthalidone in their synthetic mixture. Method I is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 251 and 227 nm i.e. λmax of Efonidipine Hydrochloride Ethanolate and Chlorthalidone, respectively. Method II is first order derivative was based on the measurement of absorbance of Efonidipine Hydrochloride Ethanolate measure at 283.2 nm (ZCP of Chlorthalidone) and absorbance of Chlorthalidone measure at 250.8 nm (ZCP of Efonidipine Hydrochloride Ethanolate). Linearity was observed in the concentration range of 6.4-38.4 µg.mL-1 for Efonidipine hydrochloride ethanolate and 2-12 µg.mL-1 for Chlorthalidone using methanol as a solvent. The accuracy of methods was assessed by recovery studies and was found to be within range of 98-102% for both the drugs. Precision of the methods was estimated by repeatability and intermediate precision studies. The % RSD values were found to be less than 2, proving methods were precise. Two methods were compared using F- test. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory.

Development and Validation of UV Spectrophotometric Method for Determination of Trimetazidine Dihydrochloride in Modified Release Tablet Formulation

Development and Validation of UV Spectrophotometric Method for Determination of Trimetazidine Dihydrochloride in Modified Release Tablet Formulation

Development and Validation of UV-spectrophotometric Method for Estimation of Berberine Hydrochloride in Marketed Formulation and Poly Lactic Co-glycolic Acid Nanoparticles

Development and Validation of UV-spectrophotometric Method for Estimation of Berberine Hydrochloride in Marketed Formulation and Poly Lactic Co-glycolic Acid Nanoparticles

Development and Validation of UV Spectrophotometric Method of Pirenzepine Dihydrochloride in API and Stress Degradation Studies

A simple, accurate, precise spectrophotometric method was developed for the detection of Pirenzepine dihydrochloride (PZC). The optimum condition for the analysis of the drug was studied. PZC was subjected to stress degradation under different conditions like acidic, alkali, neutral, oxidation, photolytic, and thermal degradation as per recommended by the International Conference on Harmonization (ICH). The samples thus prepared were used for degradation studies by with the developed method. The lambda max i.e. absorption maxima found at 281nm and calibration curve linear over the range of 0-20µg/ml. The standard regression equation and correlation coefficient fond to be y = 0.04x + 0.056 R² = 0.998 respectively. Percent RSD found to be less than one. The accepted limits of accuracy (recovery) were found to be 90% - 120% and all observed data are within required range which indicates good recovery value. and LOD and LOQ found to be 0.165 and 0.500 respectively by simple UV spectroscopy.

Development and Validation of UV Spectrophotometric Method for Doxazosin Mesylate in Bulk and Tablets

Doxazosin mesylate (DX) is an antihypertensive agent belonging to BCS class II. There is no reported literature available on development of spectrophotometric method for its analysis in bulk and pharmaceutical dosage forms using 0.1N HCl. Thus, attempt was made to develop and validate a new UV spectrophotometric method using 0.1N HCl as the solvent for its quantitative estimation in tablets that would be fast, simple, accurate, and sensitive. DX had a maximum absorbance wavelength of 245 nm and was linear with a correlation coefficient (R2) of 0.9981 across the concentration range of 2-14 μg/mL. The present method was utilized to determine the drug content of two commercial brands namely; brand I and brand II. The estimated amount of DX was 99.13% and 99.02% in these brands, respectively. The proposed method generated results that confirm the label claim and was accurate, precise, sensitive, and rugged during its validation study. The accuracy of the technique was tested using recovery research at three different levels, namely 80%, 100%, 120%, and the percent recovery rate was determined between 98% and 102% suggesting that the proposed approach is accurate. Precision and robustness were within the acceptable limits, complying with ICH standards. The proposed method could be used to quantify DX in API and dosage forms.

Development and validation of UV spectrophotometric method for trimethoprim in pure and marketed formulation

Trimethoprim drug is an aminopyrimidine antibiotic with a methylene bridge linking the pyrimidine 2,4-diamine and 1,2,3-trimethoxybenzene functional groups.It is helpful in the treatment of UTI (Urinary Tract infection). A rapid and sensitive method was develop for the analysis of Trimethoprim in both pure and tablet dosage form. The Methanolic solution of trimethoprim pure drug at room temperature (25 ± 10C) was absorbed at a maximum of 285 nm. Under optimal and validated test conditions ,Beer's rule was obeyed in the 10 – 60 μg / ml concentration range. The experiment was conducted for linearity, accuracy, precision(Intra day & interday precision), Range, detection limits, quantification limits, robustness, and ruggedness. The trimethoprim was also analysed by preformulation parameters with respect to Melting point, solubility,determination of λmax, calibration curve .The assay of marketed formulation was also performed.

Quantitative Spectrophotometric Analysis of Celecoxib and Tramadol in Their Multimodal Analgesia Combination Tablets.

Pain is a global, complex health problem that includes physical, emotional, and social components. The pain management process has many goals, including patient satisfaction, reducing clinical complications, and lowering costs. The physician describes pain medications in terms of the proven cause and classification of the severity of the pain. The combination of celecoxib and tramadol was recently approved by the Food and Drug Administration (FDA) in October 2021 for the treatment of acute pain in adults. This paper presents the first published quantitative analytical methods for celecoxib and tramadol. The UV absorption spectra of celecoxib and tramadol showed strong overlap. Mathematical simultaneous equation and ratio difference methods were developed to resolve the spectral overlap and quantify the drugs in the combination mixture. In the simultaneous equation method, the absorbance and absorptivity values at 252 and 217 nm were used to construct two mathematical equations that were used for the simultaneous mathematical quantification of the above drugs. The mathematical manipulation of the ratio difference based on the calculation of the differences in the amplitude values between 250 and 280 nm enabled the quantitative analysis of celecoxib, and the differences in the amplitude values between 221 and 272 nm enabled the quantitative analysis of tramadol. The proposed methods were successfully applied to the selective quantitative analysis of celecoxib and tramadol in the synthetic mixtures and in the pharmaceutical tablets without interference from the tablet additives. The applied methods demonstrated good linearity in the concentration range of 1-20 µg/mL and 3-45 µg/mL for celecoxib and tramadol, respectively, with acceptable accuracy and precision. The methods were found to be sensitive with LOD values of 0.183 µg/mL and 0.626 µg/mL for celecoxib and tramadol, respectively, in simultaneous equation method and of 0.275 µg/mL and 0.772 µg/mL for celecoxib and tramadol, respectively, in ratio difference method. The first established simple and validated UV spectrophotometric methods were described for concurrent quantification of the celecoxib and tramadol in their recently approved pharmaceutical formulation.

Development and validation of stability indicating UV-visible spectrophotometric method for simultaneous determination of salbutamol sulphate and ambroxol hydrochloridein liquid dosage form

Purpose: A new, simple, precise and validated UV spectrophotometric method has been developed for simultaneous estimation of salbutamol sulphate and ambroxol hydrochloride in liquid dosage form. Method: The method employed was simultaneous equation method which involves solving simultaneous equations based on measurement of absorbance at two wavelengths 224 nm and 244 nm, the λmax of salbutamol sulphate and ambroxol hydrochloride, respectively. Specificity of the method was determined by subjecting the drugs to various stress conditions like acid, alkali, thermal and photolytic degradation. Results: The linearity was obtained in the concentration range of 0.1-0.6 μg/mL for salbutamol sulphateand 1.5-09 μg/mL for ambroxol hydrochloride. The proposed method was effectively applied to liquid dosage form for estimation of both drugs. The accuracy and reproducibility results are close to 100% with ≤2% RSD. The results of proposed method have been validated as per ICH guidelines. Conclusion: A novel, precise and accurate stability indicating spectrophotometric method has been developed for the estimation of salbutamol sulphate and ambroxol hydrochloride in pharmaceutical syrup formulation.

Application of Different UV Spectrophotometric Methods for Quantitative Analysis of Acotiamide and Esomeprazole.

Acotiamide and esomeprazole are co-administrated and prescribed for gastrointestinal disorder diseases. Development of the first UV spectrophotometric methods for the quantitative analysis of acotiamide and esomeprazole in their mixture. The UV absorption spectra of acotiamide and esomeprazole showed severe overlapping. To solve the spectral overlapping and quantify the studied drugs in their mixture, simultaneous equation and ratio difference methods were developed. For simultaneous equation method, the absorbance and absorptivity values at 279 and 302 nm were used to construct two mathematical equations applied for the spectrophotometric assay of the cited drugs. Ratio difference spectra manipulated method was developed and enabled successful quantitative determination of acotiamide and esomeprazole. The differences in the amplitude values between 280 and 260 nm enabled estimation of acotiamide, and the differences in the amplitude values between 303 and 282 nm enabled estimation of esomeprazole. The proposed methods succeeded to quantify acotiamide and esomeprazole in the synthetic mixtures and in their pharmaceutical tablets without any interference from each other or from tablet additives. The applied methods demonstrated good linearity in the concentration range of 2-30 µg/mL and 2-20 µg/mL for acotiamide and esomeprazole, respectively, with acceptable accuracy and precision. The methods were found to be sensitive with LOD values of 0.336 µg/mL and 0.332 µg/mL for acotiamide and esomeprazole, respectively, in simultaneous equation method and of 0.410 µg/mL and 0.333 µg/mL for acotiamide and esomeprazole, respectively, in ratio difference method. Simple and validated UV spectrophotometric methods were described for selective quantification of the acotiamide and esomeprazole in their mixture.

Design and invitro evaluation of gastro retentive oral matrix tablet formulations of ketorolac tromethamine

Ketorolac Tromethamine floating tablets were prepared by using combination of hydrophilic polymers such as Hydroxy Propyl Methyl Cellulose 4000 cps grade and 100000 cps grade. Eight set of formulations were prepared by gradual increasing and decreasing concentrations of above two polymers. The floating pattern was found to be instant for all the formulations and best controlled release profile was achieved for few set of formulations. The drug content, tablet weight, friability and weight variation were found to be within the limits. Validated UV spectrophotometric method was developed and standard linear regression was used to determine the concentration of released drug during the course of dissolution. The release studies were subjected to zero order, first order, higuchi and ritger-peppas kinetics and the parameters for controlled release were calculated.