Validated UV Spectrophotometric Methods for the Estimation of Letrozole in Solid Dosage Forms

2018 ◽  
Vol 11 (3) ◽  
pp. 4129-4135
Author(s):  
Suryakanta Swain ◽  
Bikash Ranjan Jena ◽  
Manohar Babu Sitty ◽  
Debi Prasad Pradhan
Keyword(s):  
Phosphate Buffer ◽  
Uv Light ◽  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Solid Dosage ◽  
Accuracy And Precision ◽  
Pharmaceutical Industries ◽  
Cost Efficient

The main intent of this research is to develop two new simple, novel, cost efficient and precise UV spectrophotometric methods for estimation of letrozole in pure and pharmaceutical dosage forms. For estimation of letrozole based on the measurement of UV light absorption, the spectras of letrozole were scanned efficiently and it exhibits maximum absorption wavelength (λmax) at 240nm for Method A and 245nm for Method B. The analysis was carried out against phosphate buffer pH 6.8 (Method A) and phosphate buffer pH 3.8 (Method B) respectively.  The drug shows linear response commencing from 0.5-20 µg/mL for both methods A & B. The regression equation was found as Y= 0.099X + 0.079 (Method A) and Y= 0.1359x + 0.0048 (Method B), and correlation coefficient were 0.999 (Method A) and 0.9999 (Method B). The method validation was accomplished as per the regulation of ICH Q2R1 guidelines for linearity, accuracy, and precision studies. These reported methods have good reproducibility with percentage RSD less than one. These methods were extended towards the formulation and there was no interruption from excipients in the formulation. Hence, these proposed methods can be effectively employed for evaluation of letrozole in quality control as well as routine analysis work in pharmaceutical industries.  

scholarly journals Uv Spectrophotometric Methods for Determination of Sofosbuvir in Pure Form and Pharmaceutical Dosage Forms in Presence of Its Alkaline Degradate

2020 ◽  
pp. 12-25
Author(s):  
Zeinab Adel Nasr ◽  
Noha S. Said ◽  
Sawsan A. Abdel-Razeq
Keyword(s):  
Good Accuracy ◽  
Dosage Forms ◽  
Difference Spectra ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Good Linearity ◽  
Ratio Difference ◽  
Accuracy And Precision ◽  
Tablet Dosage

Aims: Two spectrophotometric methods were developed and validated for the determination of sofosbuvir in presence of its alkaline degradate. Study Design: Ratio difference and ratio derivative methods were assisted for determination of sofosbuvir in presence of its alkaline degradate, laboratory-prepared mixtures and in tablet dosage forms. Place and Duration of Study: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al - Azhar University, between December 2019 and January 2020. Methodology: Two analytical methods were achieved and validated for the quantitative determination of Sofosbuvir in presence of its alkaline degradate. The first method was ratio difference (RD) method, where the UV absorption spectra of different concentrations of sofosbuvir were divided by the spectrum of a certain concentration (15 µg mL-1) as a devisor of its alkaline degradate to get the ratio difference spectra. Afterwards, the peak amplitudes difference between 253.7 and 243.5 nm were measured. The second method was the ratio derivative (1DR) method, where the first derivative of the ratio spectra (1DR) was obtained and its amplitude was measured at 247 and 268 nm. Good linearity was obtained over the concentration range of 3-15 µg mL-1 for the proposed methods. The proposed procedures were adopted for the selective determination of intact Sofosbuvir in presence of up to 80% of its degradation product. Sofosbuvir was exposed to different conditions as alkaline, acidic and oxidative degradation. Results: The proposed methods were developed and validated with good linearity range of 3-15 µg mL-1 for both methods, and also with good accuracy and precision. And the obtained results were statistically compared to those obtained by the reported method. Conclusion: Sofosbuvir was successfully determined by the proposed ratio difference and ratio derivative methods in bulk powder, laboratory prepared mixtures and tablet dosage form with good accuracy and precision. The methods were validated according to ICH guidelines. The results obtained were compared with those of the reported method and were found to be in good agreement.

scholarly journals Optimization of Two Flow-Injection Spectrophotometric Methods for the Determination of Indapamide in Pharmaceutical Dosage Forms

2005 ◽  
Vol 88 (4) ◽  
pp. 1148-1154 ◽  
Author(s):  
Juan C Rodríguez ◽  
Julia Barciela ◽  
Sagrario García ◽  
Carlos Herrero ◽  
Rosa M Peña
Keyword(s):  
Flow Injection ◽  
Screening Method ◽  
Pharmaceutical Preparations ◽  
Dosage Forms ◽  
Response Surfaces ◽  
Subsequent Formation ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision

Abstract Multivariate experimental design has been used to optimize 2 flow-injection spectrophotometric methods for the determination of indapamide in pharmaceutical dosage forms, both pure and commercial tablets. The methods are based on the oxidation of this drug with iron (III) in acidic medium and the subsequent formation of an intensive orange-red complex between the liberated iron (II) and 2,2′-bipyridyl or 1,10-phenanthroline reagents. Plackett-Burman designs were applied as a screening method to evaluate the most significant factors with few experiments. Central composite 23+ star designs were performed to evaluate the response surfaces. The methods have been fully validated and were applied successfully to the determination of indapamide in pure and pharmaceutical forms with good accuracy and precision. Therefore, the 2 proposed procedures are simple, inexpensive, and rapid flow methods for the routine determination of indapamide in pharmaceutical preparations.

Effect of UV light exposure on hydrophilic polymers used as drug release modulators in solid dosage forms

2005 ◽  
Vol 15 (2) ◽  
pp. 151-157 ◽  
Author(s):  
E. Ochoa Machiste ◽  
L. Segale ◽  
S. Conti ◽  
E. Fasani ◽  
A. Albini ◽  
...  
Keyword(s):  
Drug Release ◽  
Uv Light ◽  
Light Exposure ◽  
Dosage Forms ◽  
Hydrophilic Polymers ◽  
Solid Dosage Forms ◽  
Solid Dosage

scholarly journals DEVELOPMENT AND VALIDATION OF NEW SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ANTIPSYCHOTIC DRUG ASENAPINE MALEATE IN PURE AND DOSAGE FORMS

2020 ◽  
pp. 62-69
Author(s):  
RAGAA EL-SHEIKH ◽  
AHLAM E. ABD ELLATEIF ◽  
ESRAA AKMAL ◽  
AYMAN A. GOUDA
Keyword(s):  
Limit Of Detection ◽  
Dosage Forms ◽  
Ion Pair ◽  
Stoichiometric Ratio ◽  
Bromocresol Purple ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision ◽  
Significant Difference

Objective: Three sensitive, simple, precise, reproducible, and validated spectrophotometric methods have been developed for the determination of anti-psychotic drug (asenapine maleate) in pure and pharmaceutical dosage forms. Methods: The methods are based on the formation of yellow-colored ion-pair complex between asenapine maleate and three acid dyes, namely, bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) with absorption maxima at 410, 414 and 416 nm, respectively. Several parameters such as pH, buffer type and volume, reagent volume, the sequence of addition and effect of extracting solvent were optimized. Results: Under the optimum experimental conditions, beer’s law is obeyed over the concentration ranges of 1.0–20, 1.0–14, and 1.0-16 μg/ml for BCP, BPB and BTB, respectively, with good correlation coefficients (0.9994-0.9998). The apparent molar absorptivity and Sandell’s sensitivity values are reported for all methods. The limit of detection (LOD) and the limit of quantification (LOQ) values are found to be 0.27, 0.30, and 0.25 μg/ml and 0.90, 1.0, and 0.83 μg/ml for BCP, BPB and BTB, respectively. The stoichiometric ratio of the formed ion-pair complexes was found to be 1:1 (drug: reagent) for all methods, as deduced by Job's method of continuous variation. Conclusion: The proposed methods were successfully applied for the determination of asenapine maleate in pharmaceutical formulations with good accuracy and precision. Statistical comparison of the results was performed using Student's t-test and variance ratio F-test at the 95% confidence level and there was no significant difference between the reported and proposed methods regarding accuracy and precision. Further, the validity of the proposed methods was confirmed by recovery studies via standard addition technique in accordance with ICH guidelines.

scholarly journals A NOVEL SPECTROPHOTOMETRIC DETERMINATION OF METHYLDOPA THROUGH TERNARY COMPLEXATION PROCEDURE USING FE(III), MN(II), AND CO(II) WITH 2-AMINOPYRIDINE

2019 ◽  
pp. 366-371 ◽  
Author(s):  
MUSTAFA JAMAL KHALEEL BICHAN ◽  
FADAM MUTEB ABDOON
Keyword(s):  
Low Cost ◽  
Dosage Forms ◽  
Optimum Conditions ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Ternary Complexation ◽  
Colored Complexes

Objective: The present study is aimed to find a three simple, low cost, accurate, rapid, and sensitive spectrophotometric methods based on the formation of ternary complexes to assay methyldopa (MTD) in both pure and pharmaceutical dosage forms. Methods: The suggested complexation procedure is based on the formation of ternary complex among MTD, 2-aminopyridine (2-Amp), and different metal cations such as [Fe(III), Mn(II), and Co(II)] to form three complexes of Fe(III)-MTD-2-Amp (A), Mn(II)-MTD-2-Amp (B), and Co(II)-MTD-2-Amp (C) in an aqueous medium. Results: The obtained colored complexes are spectrophotometrically measured for the previously mentioned complexes at 572, 473, and 465 nm, respectively. Under optimum conditions, the complexes exhibited apparent, molar absorptivities of 1810.62, 2954.18, and 2596.8 l/mol/cm, Sandell’s sensitivity of 0.132, 0.08, and 0.092 μg/cm2, and Beer–Lambert’s law is obeyed over the ranges 4–40, 4–32, and 4–40 μg/ml for the three developed methods, respectively. Conclusion: The developed spectrophotometric methods showed excellent results in regard to accuracy and precision with recovery of 99.48±1.62%, 100.24±1.76%, and 100.72±1.65% of the complexes A, B, and C, respectively. The obtained results are compared statistically with a reported method with respect to t- and F-tests and the calculated results displayed no significant difference.

scholarly journals Natural Super-Disintegrant Agents Used in Various Oral Solid Dosage Forms

2021 ◽  
Vol 11 (1) ◽  
pp. 110-113
Author(s):  
V.T. Iswariya ◽  
Nambaaru Sailaja ◽  
CH. Vamsi Krishna ◽  
G.S. Annammadevi
Keyword(s):  
Dissolution Rate ◽  
Oral Bioavailability ◽  
Dosage Forms ◽  
Vital Role ◽  
Solid Dosage Forms ◽  
Formulation Design ◽  
Pharmaceutical Dosage Forms ◽  
Solid Dosage ◽  
Chewable Tablets

Super-disintegrating agents are one of the ingredients used in pharmaceutical solid dosage forms. These substances play a vital role in formulation design.  Natural super-disintegrants have gained more popularity due to their oral bioavailability. It disintegrates the tablets into smaller particles to enhance the dissolution rate. Fast dissolving, chewable tablets, and other orally administered dosage forms consist of super-disintegrating agents which shows rapid and quick action. Natural super disintegrating agents in pharmaceutical dosage forms are very effective due to their ecofriendly nature as well as these are biocompatible and biodegradable. These are abundantly and cheaply available from nature.Today the researchers are focusing on naturally available excipients. Keywords: Natural Superdisintegrants, Disintegration, Bioavailability, Biocompatible, Biodegradable.

scholarly journals RP-HPLC and UV Spectrophotometric Analysis of Paracetamol, Ibuprofen, and Caffeine in Solid Pharmaceutical Dosage Forms by Derivative, Fourier, and Wavelet Transforms: A Comparison Study

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Hoang Vu Dang ◽  
Huong Truong Thi Thu ◽  
Ly Dong Thi Ha ◽  
Huong Nguyen Mai
Keyword(s):  
Phosphate Buffer ◽  
Wavelet Transforms ◽  
Dosage Forms ◽  
Spectrophotometric Analysis ◽  
Ternary Mixtures ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Rp Hplc ◽  
Spectrophotometric Data ◽  
Individual Bands

Different signal-transforming algorithms were applied for UV spectrophotometric analysis of paracetamol, ibuprofen, and caffeine in ternary mixtures. Phosphate buffer pH 7.2 was used as the spectrophotometric solvent. Severe overlapping spectra could be resolved into individual bands in the range of wavelengths 200–300 nm by using Savitzky–Golay smoothing and differentiation, trigonometric Fourier series, and mother wavelet functions (i.e., sym6, haar, coif3, and mexh). To optimize spectral recoveries, the concentration of various types of divisors (single, double, and successive) was tested. The developed spectrophotometric methods showed linearity over the ranges 20–40 mg/L for paracetamol, 12–32 mg/L for ibuprofen, and 1–3.5 mg/L for caffeine (R2 > 0.990). They could be successfully applied to the assay and dissolution test of paracetamol, ibuprofen, and caffeine in their combined tablets and capsules, with accuracy (99.1–101.5% recovery) and precision (RSD < 2%). For comparison, an isocratic RP-HPLC analysis was also developed and validated on an Agilent ZORBAX Eclipse XDB–C18 (150 × 4.6 mm, 5 µm) at an ambient temperature. A mixture of methanol : phosphate buffer 0.01 M pH 3 (30 : 70 v/v) was used as the mobile phase delivered at 2 mL/min, and the effluent was monitored at 225 nm. It was shown that spectrophotometric data were statistically comparable to HPLC p>0.05, suggesting possible interchange between UV spectrophotometric and HPLC methods for routine analysis of paracetamol, ibuprofen, and caffeine in their solid pharmaceutical dosage forms.

Evaluation of an Automated Dual-Channel Hydroxylamine Assay Procedure for Formulated Penicillin Products. I. Liquid Formulations

1974 ◽  
Vol 57 (6) ◽  
pp. 1314-1324 ◽  
Author(s):  
Jonathan R Lane ◽  
Foster McClure ◽  
Charles Martinez
Keyword(s):  
Dosage Forms ◽  
Flow Diagram ◽  
Liquid Sample ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Dual Channel ◽  
Assay Procedure ◽  
Accuracy And Precision ◽  
Wide Range ◽  
On Line

Abstract The automated dual-channel hydroxylamine method reported by Stevenson, Bechtel, and Coursen was compared with the official Food and Drug Administration (FDA) manual iodometric method used to determine the potency of formulated penicillin products. In order to assay a wide range of products, the liquid sampler module was used with 4 different flow diagram arrangements for liquid sample solutions. Solid dosage forms, when tested intact, were assayed with a modified SOLIDprep Sampler unit. Some dosage forms were assayed directly from their pharmaceutical market containers via on-line dilution techniques. Some of the problems encountered are described and experimental design as well as methods of statistical analysis are discussed. The method reported has been recommended as an alternative to the official FDA manual procedure. In general, the automated hydroxylamine method compared well in accuracy and precision with the manual iodometric method. Manually diluted autoanalysis lacked the precision of other methods.

3D Printing Technology in Pharmaceutical Dosage forms: Advantages and Challenges

2021 ◽  
Vol 22 ◽  
Author(s):  
Prasanna Kumar Desu ◽  
Balaji Maddiboyina ◽  
Vanitha K. ◽  
GSN Koteswara Rao ◽  
Anusha R. ◽  
...  
Keyword(s):  
3D Printing ◽  
Low Cost ◽  
Three Dimensional ◽  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Printing Technology ◽  
Pharmaceutical Dosage Forms ◽  
3D Printing Technology ◽  
Solid Dosage ◽  
Personalized Medicines

Three Dimensional (3D) Printing is a promising method for quick prototyping and manufacturing of any material. It is similar to photocopy or printing, where the new materials are formed on layers (3D) like its mother component. Following its growth and advancement in the 1980s, its application in pharmaceuticals is still limited. It has become one of the most innovative and influential tools serving as a technology of precise manufacturing of developed dosage forms from the last decade. The potential of 3D printing to produce drugs for precise measurement customized to specific patients' needs has shown the possibility of developing personalized medicines to novel dosage forms. The breakthrough allows the clear perception of the dosage structures on different shapes, sizes, and surfaces challenging to deliver using Designed conditions. There are different difficulties related to the correct utilization of 3D imprinting in the pharmaceutical Part, which ought to be defeated to abuse the extent of this technology. Recent advancements in the field of 3D printing technology used in the pharmaceutical industry mainly focused on different techniques for the fabrication of different dosage forms. The Food and Drug Administration's (FDA) recent approval of the first 3D prescription highlights possibilities for 3D printing innovation in the pharmaceutical drug supply field. This analysis assesses 3D printing advancement possibilities, particularly in the area of custom prescriptions. This technology can be regarded as the future of demand-produced, low-cost solid dosage forms, and helps minimize side effects due to overdose.

scholarly journals Validation of a UV Spectrophotometric Method for the Determination of Melatonine in Solid Dosage Forms

2001 ◽  
Vol 84 (5) ◽  
pp. 1352-1357 ◽  
Author(s):  
Renato F Pérez ◽  
Igor G Lemus ◽  
Rony V Bocic ◽  
Mauricio V Pérez ◽  
Rubén García-Madrid
Keyword(s):  
Accurate Method ◽  
The United States ◽  
Dosage Forms ◽  
Content Uniformity ◽  
Solid Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Solid Dosage ◽  
Pharmaceutical Form ◽  
Ph Range

Abstract The aim of the work described in this paper was to provide a fast, easy, inexpensive, precise, and accurate method for the determination of melatonine in solid pharmaceutical dosage forms. The developed method is based on a UV first-derivative spectrophotometric determination, which exhibits excellent linearity in aqueous solutions (r2 = 0.996) for analyte concentrations of 1.5–4.5 mg/dL within a pH range of 5–9. Neither excipients present in the formulation nor indole adulterants, such as tryptophan (up to 5%), interfere with the assay. A study of variation parameters showed that sonication temperature was the main factor for successful determination. At temperatures of &lt;45°C, the sample dissolved completely, and accurate spectrophotometric measurements were obtained. A study was conducted of all the parameters established by the United States Pharmacopeia, 23rd Rev., to validate an analytical method for a solid pharmaceutical form, i.e., linearity, range, accuracy, precision, and specificity. All the parameters were in accordance with the acceptance criteria of the Comité de Guías Oficiales de Validación de la Dirección General de Control de Insumos para la Salud de Méjico. In addition, robustness and content uniformity tests were performed to substantiate the usefulness of the method.

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