Derivative UV Research Articles

Development and Validation of a Novel Second Derivative UV Method for the Estimation of Antihypertensive Drugs in Tablet Dosage Form

Development and Validation of a Novel Second Derivative UV Method for the Estimation of Antihypertensive Drugs in Tablet Dosage Form

Determination of levofloxacin, norfloxacin, and moxifloxacin in pharmaceutical dosage form or individually using derivative UV spectrophotometry

PurposeIn this study, first, second, third, and fourth-order derivative spectrophotometric methods utilizing the peak—zero (P—O) and peak-peak (P—P) techniques of measurement were developed for the determination of levofloxacin, norfloxacin, and moxifloxacin. These methods were applied to their combined pharmaceutical dosage form or individually for levofloxacin, norfloxacin, and moxifloxacin.MethodsLinearity was established in the concentration range of 2–20 µg/mL. The procedures are simple, quick, and precise. The developed methods are sensitive, accurate, and cost-effective, demonstrating excellent correlation coefficients (R2 = 0.9998) and mean recovery values ranging from 99.20% to 100.08%, indicating a high level of precision.ResultsThe developed approach was effectively employed to determine the levofloxacin, norfloxacin, and moxifloxacin content in commercially available pharmaceutical dosages.ConclusionsStatistical analysis and recovery tests confirmed the method's linearity and accuracy. The results suggest that this method can be utilized for routine analysis in both bulk and commercial formulations. The simplicity, accuracy, and cost-effectiveness of the developed methods make them valuable for pharmaceutical analysis.

Derivative UV Spectroscopic Cleaning Method Development and Validation of Darunavir API incorporated into Dissolving Oral Film

A new UV spectrophotometric technique was developed and validated for Darunavir API by using oral film. The drug was analyzed using a UV spectrophotometric technique, and its linearity, accuracy, precision, and robustness were determined by ICH guidelines. Acetonitrile was the solvent used, and 263nm was shown to be the wavelength. R2=0.9989 shows that the method was linear in the range of 2 to 16µg/ml. Method precision was carried out and RSD was found to be 0.933. The accuracy values obtained from testing at three levels were 99.8, 100.7, and 99.4 in (50,100,150%). The residues are collected using the swab sample technique on a 10cm2 stainless steel plate. To collect the residue, swab sticks are used to stripe the SS plate in three directions: horizontally, vertically, and diagonally. Forced Degradation studies were conducted for API and Synthetic mixture at various conditions and the % degradation was recorded. The proposed method was used for the synthetic mixture of Darunavir API which has its application in formulating OSD. An assay of oral films was done which obeys the beers lambert law in the concentration of 3.27µg/ml. Recovery studies gave statistical confirmation and support for the analysis's conclusions

Eco-friendly spectrophotometric methods for concurrent analysis of phenol, 2-aminophenol, and 4-aminophenol in ternary mixtures and water samples: assessment of environmental sustainability.

Recently, there has been a high demand for green procedures in analytical chemistry, particularly those utilizing eco-friendly solvents. In this context, three feasible derivative UV spectrophotometric methods namely, derivative ratio-zero crossing spectra (DRZCS), double divisor ratio spectra (DDRS), and successive derivative subtraction coupled with constant multiplication (SDS-CM) were developed to quantify a ternary mixture of phenol (P), 2-aminophenol (2-AP), and 4-aminophenol (4-AP) in real water samples simultaneously, using ethanol as a solvent. The established methods demonstrated a good linear range, covering 2-60 μg mL-1 for P and 2-50 μg mL-1 for 2-AP and 4-AP, in all approaches with a high correlation coefficient (R2 ≥ 0.9995). In compliance with ICH guidelines, the methods exhibited acceptable precision and accuracy, as indicated by good spike recovery with low relative standard deviations. The eco-friendliness of the UV spectrophotometric approach was assessed using analytical eco-scale (AES), analytical greenness (AGREE), and analytical greenness metrics for sample preparation (AGREEprep). These evaluations confirmed the eco-friendliness of the proposed methods in terms of solvents, energy consumption, and waste generation. The proposed procedure proved to be efficient in quantifying each component in laboratory-synthesized mixtures and real water samples, thanks to its simplicity, accuracy, sensitivity, and cost-effectiveness.

What to consider for successful administration of oral liquids via enteral feeding tubes? a case study with paediatric ibuprofen suspensions

Administration of medications via enteral feeding tubes (EFTs) is a common practice for children who cannot swallow properly. Although liquid formulations are the preferred dosage forms for this route of administration, little attention has been paid to the amount of drug that reaches the site of absorption after administration via an EFT. This systematic in vitro study aimed to identify formulation parameters and administration approaches that are critical for successful dose delivery via EFTs. For this purpose, drug recovery after administration of three different paediatric ibuprofen suspensions via different types of EFTs was studied using derivative UV spectrophotometry for quantification. Study results indicate that in addition to formulation parameters, feeding tube characteristics and the administration process can have a significant impact on the administered dose. The ratio between the total administered fluid volume (TAV), represented by the sum of dose- and flushing volume, and the feeding tube volume (FTV) proved to be a valuable indicator for assessing successful administration. Incorrect dosing and complications could be avoided if the TAV/FTV ratio was greater than 4. This and other knowledge gained in the study will help to make the administration of liquid paediatric medicines via EFTs both more effective and safer.

Vortioxetine Estimation in its Drug Formulations by fist order derivative UV Spectrophotometric Method

For the simultaneous estimation of Vortioxetine Hydrochloride pharmaceuticals, a simple, accurate, precise, and reproducible method has been developed. For Quantitative Analysis of First Order Derivative, no UV methodologies have been described, it was felt that a novel approach to drug analysis using methanol as a solvent was required. Vortioxetine hydrochloride has absorbance maximum at 230 nm. This drug obeys Beer's law in concentration range of 10-50µg/ml. The recovery studies confirmed the proposed method's accuracy, and the results were validated in accordance with ICH guidelines. The outcomes were found to be satisfactory and reproducible. Thus the proposed method can be successfully applied for the quantitative analysis of Vortioxetine hydrochloride.

Development and Validation of Derivative UV Spectrophotometric method for Simultaneous Determination of Amoxicillin and Clavulanic acid in Tablets (Augmentin 1000mg)

The simultaneous analysis of pharmaceutical mixtures by classical spectrophotometric methods without prior separation is a challenge owing to the strong overlapping of their zero order spectra (low selectivity). Hence, several techniques have been developed for solving this problem, such as derivative spectrophotometry. The aim of this study was to develop a simple, fast, accurate, precise, economical, and eco-friendly derivative spectrophotometric method for the quantitative determination of a binary mixture of amoxicillin (Amox) and clavulanic acid (Clav) without prior separation steps. The developed method is based on the use of first derivative spectra resulting from derivatisation of zero order, with using these parameters (d𝛌=4 and scaling factor=15). The measurements were achieved by using zero-crossing technique (𝛌= 278.5nm for Amox and 𝛌= 228.3nm for Clav), which eliminated the overlapping caused by two drugs and excipients of tablets. The method showed significant linearity in the range (5 45μg/ml with =0.9998) and (1 - 10μg/ml with =0.9986) for Amox and Clav, respectively. The developed technique was validated according to the ICH guidelines. The method was successfully utilized for the simultaneous determination of Amox and Clav in the formulation. The obtained results were statistically compared with the reported method (HPLC) by applying t-test and F-value at 95% confidence level. No significant difference was observed regarding accuracy and precision. Hence,the proposed procedure can be utilized for regular quality control studies as alternative to chromatographic techniques.

Development and Validation of Analytical Methods for Simultaneous Estimation of Lercanidipine Hydrochloride and Enalapril Maleate

The fixed dose of lercanidipine hydrochloride(LH) and enalapril maleate (EM) is used to provide more effective control of hypertension. The research work was aimed at the development and validation of simple and sensitive analytical methods for their quantification from tablets. The simultaneous equation, first-order derivative, and multivariate spectrophotometric methods were developed for the simultaneous estimation of LH and EM in tablets. The simultaneous equation method involves a determination of LH and EM at 236 nm and 207 nm, respectively. First order derivative UV spectrophotometry method involves using a zero crossing point of LH at 330 nm and EM at 219 nm. Both methods were validated as per ICH Q2 (R2) guidelines and found to be accurate and precise as they exhibited <2% relative standard deviation. The limit of detection (LOD) and limit of quantitation (LOQ) for LH were found to be 0.26 μg/ml and 0.78 μg/ml respectively whereas LOD and LOQ for EM were found to be 0.41 μg/ml and 1.24 μg/ml respectively for simultaneous equation method. The LOD and LOQ for LH were found to be 0.39 μg/ml and 1.19 μg/ml respectively whereas LOD and LOQ for EM were found to be 0.31 μg/ml and 0.97μg/ml respectively for the first-order derivative method. Three Chemometric methods namely classical least square (CLS), principal component regression (PCR), and partial least square (PLS) were studied for the simultaneous determination of LH and EM in tablets using spectrophotometry. A set of 25 standard mixtures containing both drugs were prepared in the range of 5–25 μg/ml for both drugs. The analytical figure of merit (FOM) was determined for all three chemometric methods. The LOD values for LH were found to be 0.97, 0.93, and 0.94 μg/ml and 0.90,0.88, and 0.89 μg/ml for EM using CLS, PCR, and PLS modeling techniques. The proposed methods were user-friendly, rapid, and sensitive enough for the determination of LH and EM.

Physicochemical stability study of a biosimilar of Bevacizumab in vials and after dilution in 0.9% NaCl in polyolefin intravenous bags

Abstract Objectives Bevacizumab was first marketed in 2005. Since then, its stability has been extensively studied. The arrival of numerous biosimilars on the market has called into question these stabilities and organisation within reconstitution units. To study the stability of the Bevacizumab biosimilar Alymsys® marketed by Zentiva laboratory in ready-to-use vials at a concentration of 25 mg/mL and following dilution to obtain final concentrations of 1.4 and 16.5 mg/mL and storage in polyolefin IV bags at 4 °C. In parallel, the impact of a storage temperature excursion at 25 °C for three days and storage of the vial before opening at room temperature (25 ± 2 °C) and after opening at 4 °C was studied. Methods The vials were supplied by Zentiva laboratory. The vials (three batches) were diluted to the final concentrations of 1.4 or 16.5 mg/mL in 100 mL IV bags of NaCl. The IV bags and vials were stored at 4 °C and at room temperature throughout the duration of the study. The physico-chemical stability was tested using the following methods: turbidimetry, UV spectrometry and fluorescence, dynamic light scattering, ion exchange and steric exclusion chromatography, pH, osmolality and density. Results Out of all the parameters studied, for the two concentrations and standard storage conditions (90 days at +4 °C) or after a three-day temperature excursion at +25 °C, no modification was detected for the three batches tested with respect to physical and chemical stability. Hence, no signs of physical instability were observed, with, in particular, the absence of formation of submicron or micron sized aggregates and particles. The steric exclusion chromatography profiles did not demonstrate any oligomer formation or molecular structure rupture. Ion exchange chromatography did not demonstrate any significant modification in the distribution of charge variants. Derivative UV and fluorescence spectral analysis did not demonstrate any modification. The thermal denaturation curves were identical, suggesting the absence of thermodynamic destabilisation. Identical results were observed for the vials stored for 60 days at 4 °C after opening. Finally, only ion exchange chromatography demonstrated a slight change after 45 days of storage at 25 °C for vials before opening. Conclusions After dilution in sterile conditions with 0.9% NaCl in polyolefin IV bags, at the usual concentrations of 1.4 and 16.5 mg/mL, the Bevacizumab biosimilar Alymsys® is stable for at least three months at 4 °C protected from light and after a three-day temperature excursion at +25 °C. The same conclusions can be reached for the 25 mg/mL vials stored for 60 days at +4 °C after opening. However, the stability of vials stored at 25 °C before opening is no longer guaranteed beyond 15 days.

HPTLC AND FIRST DERIVATIVE UV-SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF VILAZODONE IN PHARMACEUTICALS

A new HPTLC method and a sensitive UV spectrophotometric method were established for estimating vilazodone hydrochloride in its pharmaceutical formulations. An environment-friendly chromatographic mobile phase consisting of ethyl acetate: toluene: formic acid (5:4:1, V/V/V) along with ultraviolet densitometric detection at 240 nm using pre-coated silica gel plates was used. First derivative UV spectrophotometric determinations were performed using methanol as solvent, and amplitudes were measured for quantification purposes. Validation studies were compliant with ICH guidance. Vilazodone shows an optimum Rf value of 0.73 ± 0.02 by HPTLC method. First derivative spectrophotometric measurements were done at 230 nm (peak) and 247 nm (valley), respectively. Best method linearity was observed in the range of 100 - 600 ng band-1 and 100 - 600 ng mL-1 for the chromatographic and spectrophotometric methods, respectively. Method detection limits were 61.4 ng band-1 and 36.03 ng mL-1, for chromatography and spectrophotometry, respectively. Higher % recovery (> 99 %) of vilazodone from the in-house formulation satisfied study intent as well as instituted selectivity of both the methods. Both the newly developed methods have the potential of application in routine quantification of vilazodone in pharmaceuticals.

Comparison of the Degree of Acetylation of Chitin Nanocrystals Measured by Various Analysis Methods.

Chitin and its derivate chitosan have versatile properties and have been used in various applications. One key parameter determining the functionality of chitin-based materials is the degree of acetylation (DA). For DA determination, NMR and FTIR spectroscopy are often considered to be the gold standard, but these techniques may not always be available and are rather time-consuming and costly. The first derivative UV method has been suggested, although accurate measurements can be challenging for materials with high degrees of acetylation, due to hydroxymethylfurfural (HMF) formation and other side reactions occurring. In this paper, we re-evaluated the first derivate UV method for chitin and chitosan powder, chitin nanocrystals, and deacetylated chitin nanocrystals. Our results showed that the first derivative UV method is capable of measuring DA with high accuracy (>0.9), leading to values comparable to those obtained by 1H NMR, 13C NMR, and FTIR. Moreover, by-product formation could either be suppressed by selecting the proper experimental conditions, or be compensated. For chitin nanocrystals, DA calculation deviations up to 20% due to by-product formation can be avoided with the correction that we propose. We conclude that the first derivative UV method is an accessible method for DA quantification, provided that sample solubility is warranted.

STABILITY INDICATING ISOCRATIC RP-HPLC AND SECOND DERIVATIVE UV SPECTROSCOPIC METHODS FOR SIMULTANEOUS DETERMINATION OF REMOGLIFLOZIN ETABONATE AND VILDAGLIPTIN HYDROCHLORIDE

Remogliflozin and Vildagliptin are the latest drug combination in order to treat type 2 diabetes. The present work describes a comparative study of 2nd-ordered derivative UV and isocratic stability indicating RP-HPLC methods for simultaneous determination of Remogliflozin and Vildagliptin in the drug and its formulation. The HPLC method was established with a C18 column and the mobile phase with Buffer (pH-6.50): Acetonitrile: Methanol ratio of 55:44:1, at 1.2 ml/min flow and wavelength of 210 nm. The UV spectrophotometric method works on spectrophotometry with 2nd order derivative spectra(2D) using a zero-line cross method. The absorbance determination was performed at 246.0 nm for REM and at 219 .6 nm for VIL. The methods were validated for Linearity, Precision, Recovery, Robustness, and Forced degradation as per ICH-Q2(R1). The linear range was established in the range of 4-80 ppm for REM and 2-40 ppm for VIL for the UV method and 2-200 ppm for REM and 1-100 ppm for VIL for the HPLC method with regression coefficient ≥0.990. The accuracy was 99.37% & 99.62% for UV and 100.98 & 100.65 for the HPLC method for REM and VIL respectively. The proposed methods have been effectively used for the quantification of REM and VIL in API mixture and formulation dosage forms. Both methods are economical, fast, simple, and accurate which can be easily adopted for laboratory use.

On particular Regimens of Derivative UV Spectrophotometry for Comparative Analysis of Proteins

On particular Regimens of Derivative UV Spectrophotometry for Comparative Analysis of Proteins

Method development and validation of solifenacin succinate in pharmaceutical dosage form using first order derivative UV spectrophotometry

Method development and validation of solifenacin succinate in pharmaceutical dosage form using first order derivative UV spectrophotometry

Comparative qualitative and quantitative assessment of selected brands of Co-trimoxazole tablets and suspensions procured from Lagos State, Nigeria using first derivative UV spectroscopy and HPLC

Background: The use of High-Performance Liquid Chromatography (HPLC) to evaluate the quality of co-trimoxazole formulations is relatively expensive, and First Derivative UV Spectroscopic (FDS) technique may be alternatively used. There are no studies evaluating the quality of locally manufactured sulphamethoxazole/trimethoprim (SMX/TMP) dosage forms procured from Lagos, Nigeria. The aim of the work was to evaluate the quality attributes of selected co-trimoxazole tablets and suspensions marketed in Lagos, Nigeria, and determine their API content using first derivative UV spectroscopy and HPLC. Methods: Ten samples each of Co-trimoxazole tablets and suspensions were procured and their quality attributes were evaluated using standard pharmacopeial methods while their drug content was quantified using FDS and HPLC methods. Results: 70 % of the tested tablet as well as all the suspension samples exhibited satisfactory quality attributes. In terms of the drug content assay, 60 % of the studied tablets and 40 % of the suspension brands were USP-compliant. The SMX and TMP content of the suspension formulations using FDS technique was generally less than that obtained using the HPLC method, suggesting that the active ingredients might have degraded. Conversely, there was good correlation in the drug content of the tablets using FDS and HPLC. Conclusion: First Derivative UV spectroscopy may be suitable to quantify the drug content of co-trimoxazole tablets while HPLC technique may be preferable for co-trimoxazole suspensions. Furthermore, stringent regulatory monitoring of the marketed co-trimoxazole products is required to assure the quality, safety and efficacy of marketed co-trimoxazole products, thereby safeguarding public health.

Comparative qualitative and quantitative assessment of selected brands of Co-trimoxazole tablets and suspensions procured from Lagos State, Nigeria using first derivative UV spectroscopy and HPLC

Comparative qualitative and quantitative assessment of selected brands of Co-trimoxazole tablets and suspensions procured from Lagos State, Nigeria using first derivative UV spectroscopy and HPLC

A REVIEW ON DERIVATIVE UV SPECTROSCOPY

This article manages the parts of hypothetical Derivative UV Spectroscopy. By utilizing this technique first and second subsidiary transmission spectra with importance, frequency is acquired. This strategy gives an important understanding of utilizations and restrictions of substance analysis. This Application of UV subsidiary spectroscopy for assurance of multi and single-component investigation is shown. It works on the awareness and selectivity for determination. Measurement techniques and techniques for getting spectra are examined.

Second derivative UV\u2013visible spectroscopy characterizing structural components of dissolved and particulate organic matter in an urbanized river

BackgroundSpatio-temporal variations of structural components of the POM–DOM fractions exhibit in urban rivers, which is valuable information to reveal dynamic migration and transformation within and between the organic matter pools, also provide important support for river water quality improvement and management measures. Second derivative UV–visible spectroscopy (SDUVS) was applied to simultaneously characterize structural components and spatial variations of dissolved (DOM: Diameter < 0.2 μm) and particulate (POM1: 0.2 < diameter < 0.7 μm; POM2: diameter > 0.7 μm) organic matters in an urbanized river of northeast China.ResultsThirty-six water samples were collected from mainstream and tributaries along a human impact gradient, i.e., rural, town and urban regions. The DOM was a representative fraction for the natural organic matter pool, which was mostly derived from allochthonous and terrestrial sources. Four components C1 to C4 were identified from the POM–DOM fractions by the SDUVS. The C1 associated with phenolic groups and the C2 related to carboxylic groups were dominant for the organic matter pool. The C3 was composed of the primary humificated materials, and the %C3 was kept relatively consistent in the organic matter pool. The C4 presented deeply humificated organic matter with the increase of aromatic and alkyl structures. The average %C4 of the POM pool was higher than that of the DOM pool, indicating that the humification degree of the POM fractions was higher than that of the DOM fraction.ConclusionsMoreover, the tributaries had a higher average %C4 within the DOM than the mainstream, and trends of the POM pool were similar to the DOM pool. The trophic level of the river water decreased in the order of urban region > town region > rural region, while the molecular sizes of the POM–DOM decreased in the order of rural region > town region > urban region.Graphical

Development and validation of derivative UV spectroscopic method for simultaneous estimation of nicotinamide and tretinoin in their binary mixtures and pharmaceutical preparations

An accurate, precise, sensitive, and simple spectroscopic method was developed and validated for simultaneous quantification analysis of tretinoin (TRT) and nicotinamide (NCT) with a ratio of 1:40 (TRT: NCT) in a synthetic mixture from dermal pharmaceutical preparations (solution and cream). Wavelengths were chosen in the first and second-order derivatives which are valid for the determination of NCT with the existence of TRT and excipients of the tested pharmaceutical preparations. Wavelength 253 nm was picked for the first-order derivative. Wavelengths 245 and 269 nm were picked for the second derivative. All previous wavelengths were zero-crossing points for TRT and its pharmaceutical preparations. Zero-order spectroscopy was used to determine TRT at the wavelength 348 nm, where no interference with NCT or any substance in the previous pharmaceutical preparation. The linearity range was studied and found to be 20–120 μg/mL and 0.5–5.0 μg/mL for NCT and TRT respectively. The correlation coefficient was 0.9995–0.9999 for NCT and 0.9998–0.9999 for TRT. The limit of detection (LOD) and the limit of quantification (LOQ) of NCT were 1.510 μg/mL and 4.590 μg/mL respectively at the wavelength 269 nm of the second-order derivative.

CHARACTERISTICS OF THE REDOX STATE OF THE LIGNIN-CARBOHYDRATE WOOD MATRIX AT THE INITIAL STAGES OF DEVELOPMENT ON THE EXAMPLE OF SCOTS PINE

The studies of wood formation at the initial stages allowed confirming the determining role of the redox transformations of monolignols in the lignification of plant matrix. The change in the composition of the phenolic fraction (conjugated and non-conjugated phenolic structures) of the phenol-quinone redox system of the cell wall was studied using the derivative and differential UV spectroscopy. It was shown that the accumulation of low-molecular phenolic compounds in the initial period of ontogenesis occurs mainly in the "needles" of plants. It was confirmed that the seedlings being removed to the hardening site adapt to the existing temperature regime. It is characterized by lower content of low-molecular phenolic compounds preventing the development of oxidative processes. The plant is exposed to oxidative stress at low temperatures, when the enzymatic (peroxidase activity) system of plant protection is activated. The change in the coniferyl alcohol content as a marker of the lignification is shown. The correlation of changes in peroxidase activity with the total content of phenolic compounds and coniferyl alcohol was shown. The IR spectroscopy method showed a change in the ratio of carbohydrate and lignin components at the initial stages of the development of seedlings of scots pine.