scholarly journals Spectrophotometric Determination of Apixaban in Bulk Drug and Oral Dosage Formulation

2019 ◽  
pp. 377-385
Author(s):  
Deepshikha Sharma ◽  
Vikramsinh R. Chauhan ◽  
Kartik B. Vyas
Keyword(s):  
Cost Effective ◽  
Oral Formulation ◽  
Oral Dosage ◽  
Colored Complex ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Bulk Drug ◽  
Dosage Formulation ◽  
Diamine Dihydrochloride

A simple, rapid, cost effective and extractive UV-Vis spectrophotometric method has been developed for the determination of Apixaban (AP) in bulk drug and pharmaceutical formulation. It was based on UV-Vis spectrophotometric measurements in which the drug reacts chromogenic reagent (N-(1-napthyl) ethylene diamine dihydrochloride solution) in acidic medium and give stable pale yellow colored complex which exhibits absorption maximum at 680 nm. Beer’s law was obeyed in the concentration range of 5 - 50 μg /ml. This method was tested and validated for various parameters according to ICH guidelines. The proposed method was successfully applied for the determination of AP in oral formulation. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 2 %). As it is simple, cheap and less time consuming, it can be suitably applied for the estimation of LA in dosage forms in quality control labs.

scholarly journals Spectrophotometric determination of Rivaroxaban in bulk drug and oral dosage formulation

2019 ◽  
pp. 576-584
Author(s):  
Vikramsinh R. Chauhan ◽  
Deepshikha Sharma ◽  
Kartik B. Vyas
Keyword(s):  
Cost Effective ◽  
Oral Formulation ◽  
Oral Dosage ◽  
Bromocresol Green ◽  
Colored Complex ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Bulk Drug ◽  
Dosage Formulation

A simple, rapid, cost effective and extractive UV-Vis spectrophotometric method has been developed for the determination of Rivaroxaban (RIV) in bulk drug and pharmaceutical formulation. It was based on UV-Vis spectrophotometric measurements in which the drug made a complex with bromocresol green dye (BCG) in acidic medium and give stable pale yellow colored complex which exhibits absorption maximum at 416 nm. Beer’s law was obeyed in the concentration range of 2 - 40 ?g /ml. This method was tested and validated for various parameters according to ICH guidelines. The proposed method was successfully applied for the determination of RIV in oral formulation. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 2 %). As it is simple, cheap and less time consuming, it can be suitably applied for the estimation of RIV in dosage forms in quality control labs.

scholarly journals Spectrophotometric Determination of Rufinamide in Bulk Drug and Oral Dosage Formulation

2019 ◽  
pp. 568-575
Author(s):  
Deepshikha Sharma ◽  
Vikramsinh R. Chauhan ◽  
Kartik B. Vyas
Keyword(s):  
Cost Effective ◽  
Oral Formulation ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Colored Complex ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Bulk Drug ◽  
Dosage Formulation

A simple, rapid, cost effective and extractive UV-Vis spectrophotometric method has been developed for the determination of Rufinamide(RFM) in bulk drug and pharmaceutical formulation. It was based on UV-Vis spectrophotometric measurements in which the drug made a complex with ?-naphthol in alkaline medium and give stable pale yellow colored complex which exhibits absorption maximum at 540 nm. Beer’s law was obeyed in the concentration range of 2 - 24 ?g /ml. This method was tested and validated for various parameters according to ICH guidelines. The proposed method was successfully applied for the determination of RFM in oral formulation. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 2 %). As it is simple, cheap and less time consuming, it can be suitably applied for the estimation of RFM in dosage forms in quality control labs.

scholarly journals Spectrophotometric Determination of Lacosamide in Bulk Drug and Oral Dosage Formulation

2019 ◽  
pp. 370-376
Author(s):  
Vikramsinh R. Chauhan ◽  
Deepshikha Sharma ◽  
Kartik B. Vyas
Keyword(s):  
Cost Effective ◽  
Oral Formulation ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Colored Complex ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Bulk Drug ◽  
Dosage Formulation

A simple, rapid, cost effective and extractive UV-Vis spectrophotometric method has been developed for the determination of Lacosamide (LA) in bulk drug and pharmaceutical formulation. It was based on UV-Vis spectrophotometric measurements in which the drug reacts chromogenic reagent 4-Chloro-7-nitrobenzo-2-oxa-1,3-diazole in alkaline medium and give stable pale yellow colored complex which exhibits absorption maximum at 420 nm.  Beer’s law was obeyed in the concentration range of 0.04 - 40 μg /ml. This method was tested and validated for various parameters according to ICH guidelines. The proposed method was successfully applied for the determination of LA in oral formulation. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 2 %). As it is simple, cheap and less time consuming, it can be suitably applied for the estimation of LA in dosage forms in quality control labs.

scholarly journals Microtitrimetric determination of a drug content of pharmaceuticals containing olanzapine in non-aqueous medium

2009 ◽  
Vol 15 (2) ◽  
pp. 77-81 ◽  
Author(s):  
Kanakapura Basavaiah ◽  
Nagaraju Rajendraprasad ◽  
Basavaiah Vinay
Keyword(s):  
Standard Deviation ◽  
Aqueous Medium ◽  
Reference Method ◽  
Standard Addition ◽  
Cost Effective ◽  
Pharmaceutical Products ◽  
Relative Standard ◽  
Bulk Drug ◽  
Point Detection

Two simple, rapid, reliable and cost-effective methods based on titrimetry in non-aqueous medium are described for the determination of olanzapine in pharmaceuticals. In these methods, the drug dissolved in the glacial acetic acid was titrated with the acetous perchloric acid with visual and potentiometric end point detection, crystal violet being used as the indicator for visual titration. The methods are applicable over 1-15 mg range of olanzapine. The procedures were applied to determine olanzapine in pharmaceutical products and the results were found to be in a good agreement with those obtained by the reference method. Associated pharmaceutical materials did not interfere. The precision results, expressed by inter-day and intra-day relative standard deviation values, were satisfactory, higher than 2%. The accuracy was satisfactory as well. The methods proved to be suitable for the analysis of olanzapine in bulk drug and in tablets. The accuracy and reliability of the methods were further ascertained by recovery studies via a standard addition technique with percent recoveries in the range 97.51-103.7% with a standard deviation of less than 2%.

scholarly journals UV Spectrophotometric Method Development and Validation of Fimasartan Drug and Its Tablet Formulation

1970 ◽  
Vol 7 (5) ◽  
pp. 25-29
Author(s):  
Kaushik S Agrawal ◽  
Lokesh R Gandhi ◽  
Nitin S. Bhajipale S Bhajipale3
Keyword(s):  
Standard Deviation ◽  
Quantitative Determination ◽  
Relative Standard Deviation ◽  
Spectrophotometric Method ◽  
Method Development ◽  
Cost Effective ◽  
Tablet Formulation ◽  
Relative Standard ◽  
Bulk Drug

A novel, safe and sensitive method of Spectrophotometric estimation in UV - region has been developed for the assay of Fimasartan in its tablet formulation. The present study was undertaken to develop and validate a simple, accurate, precise, reproducible and cost effective UV spectrophotometric method for the estimation of Fimasartan bulk and pharmaceutical formulation. The method have been developed and validated for the assay of Fimasartan using Methanol as diluent. Absorption maximum (λmax) of the drug was found to be 240nm. The quantitative determination of the drug was carried out at 240nm. The method was shown linear in the mentioned concentrations having correlation coefficient R2 of 0.999. The recovery values for Fimasartan ranged from 98.74% to 99.23%.The Percent Relative Standard Deviation of interday and intraday was 0.85% and 0.75% respectively. All the parameters of the analysis were chosen according to the International Conference on Harmonisation guideline and validated statistically using Relative Standard Deviation and Percent Relative Standard Deviation. Hence, proposed method was precise, accurate and cost effective. This method could be applicable for quantitative determination of the bulk drug as well as dosage formulation.   KEY WORDS: 

scholarly journals Analytical Method Development and Stability Studies for Estimation of Oseltamivir In Bulk and Capsules Using RPHPLC

2020 ◽  
Vol 13 (1) ◽  
pp. 107-116
Author(s):  
Siva Sanker Reddy L ◽  
B. Mohammed Ishaq ◽  
GundaSai Mounica
Keyword(s):  
Method Development ◽  
Degradation Products ◽  
Hplc Method ◽  
Test Method ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Effluent Flow Rate ◽  
Reproducible Method ◽  
Bulk Drug

A simple and reproducible method of isocratic reverse phase liquid chromatography (RP-LC) was developed for the quantitative determination of oseltamivir phosphate in bulk drug and capsules, used to treat antiviral (influenza). The proposed RP-HPLC method uses X terra C18, 4.6 mm, 150 mm 4.6 mm i.d. column (at room temperature), using 0.1% octa-sulfonic acid: acetonitrile 30: 70 v / v, effluent flow rate (1.0 ml / min) and UV detection at 237 nm for oseltamivir analysis. The method was validated according to the ICH guidelines in terms of specificity, linearity, precision and accuracy. The retention time for oseltamivir was 2.31 min. The recovery determinations allowed the calculation of a confidence interval from 99.79 to 101.30% with a relative standard deviation value of 0.5%. LOD and LOQ were estimated at 2.98 and 9.98 µg/mL respectively. The validated method was successfully applied to the determination of oseltamivir in dosage form in capsules (Tamiflu 75 mg, Roche). Oseltamivir was exposed to conditions of acid, basic, oxidative and thermal stress and the stressed samples were analyzed with the proposed method. The chromatographic peak purity results indicated the absence of elution peaks with the main oseltamivir peak, which demonstrated the specificity of the test method for estimating oseltamivir in the presence of degradation products. This method has advantages that include a short execution time, a simple and rapid sample preparation which makes this method used for routine oseltamivir analysis in quality control laboratories.

scholarly journals Development and validation of colorimetric method for the determination of pregabalin in bulk and pharmaceutical formulations

2020 ◽  
Vol 11 (4) ◽  
pp. 5896-5901
Author(s):  
Areej Abdelmonim Mohamed ◽  
Tilal Elsaman ◽  
Mohammed E Adam ◽  
Elrasheed A Gadkariem ◽  
Shaza W Shantier
Keyword(s):  
Colorimetric Method ◽  
Pharmaceutical Formulations ◽  
Colored Complex ◽  
Standardized Residuals ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Complex Development ◽  
Reaction Stoichiometry ◽  
Development And Validation

A simple, accurate and precise colorimetric method was developed for the quantification of pregabalin (PGN) in bulk and pharmaceutical formulations. The method was based on the production of a colored complex by reacting PGN with ascorbic acid in DMSO solvent. The resultant complex exhibits absorption maxima at 390 and 532 nm. The factors that affect the complex development and stability were studied and optimized. The reaction stoichiometry of drug: reagent was found to be 1:2. The method was then validated according to ICH guidelines. Regression analysis of Beer's plot showed good correlation (r2 value more than 0.998) within a concentration range of 5-30μg/ml. Linearity was confirmed by standardized residuals versus fitted value plots using Minitab14 software. The limits of detection and quantification at 390 and 532nm were 1.34μg/ml, 1.09μg/ml and 4.05μg/ml, 3.294μg/ml, respectively. Added recovery measurements were found to be 100.04±2.07% and 99.58 ±1.98% at 390nm and 532nm, respectively, which reflect the accuracy of the method and freedom from interference (relative standard deviation values were less than or equal 0.2%). The average assay for the commercial capsule preparation (PGN 150mg/capsule) was found to be 101.373±0.49 and 101.812±0.73 at 390 and 532nm, respectively. The developed method is an inexpensive, extraction free and can be applied for routine analysis of PGN in most of analytical laboratories.

scholarly journals Development and Validation of UV Spectrophotometric Method for the Determination of Cefuroxime Axetil in Bulk and Pharmaceutical Formulation

2013 ◽  
Vol 6 (1) ◽  
pp. 133-141 ◽  
Author(s):  
S. Binte Amir ◽  
M. A. Hossain ◽  
M. A. Mazid
Keyword(s):  
Spectrophotometric Method ◽  
Cost Effective ◽  
Cefuroxime Axetil ◽  
Pharmaceutical Formulation ◽  
Uv Spectrum ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Label Claim ◽  
Development And Validation

The present study was undertaken to develop and validate a simple, sensitive, accurate, precise and reproducible UV spectrophotometric method for cefuroxime axetil using methanol as solvent. In this method the simple UV spectrum of cefuroxime axetil in methanol was obtained which exhibits absorption maxima (?max) at 278 nm. The quantitative determination of the drug was carried out at 278 nm and Beer’s law was obeyed in the range of (0.80-3.60) µg/ml. The proposed method was applied to pharmaceutical formulation and percent amount of drug estimated (95.6% and 96%) was found in good agreement with the label claim. The developed method was successfully validated with respect to linearity, specificity, accuracy and precision. The method was shown linear in the mentioned concentrations having line equation y = 0.05x + 0.048 with correlation coefficient of 0.995. The recovery values for cefuroxime axetil ranged from 99.85-100.05. The relative standard deviation of six replicates of assay was less than 2%. The percent relative standard deviations of inter-day precision ranged between 1.45-1.92% and intra-day precision of cefuroxime axetil was 0.96-1.51%. Hence, proposed method was precise, accurate and cost effective.  Keywords: UV-Vis spectrophotometer; Method validation; Cefuroxime axetil; Recovery studies.  © 2013 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.   doi: http://dx.doi.org/10.3329/jsr.v6i1.14879 J. Sci. Res. 6 (1), 133-141 (2013)  

RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF AMPHOTERICIN B

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (02) ◽  
pp. 16-20
Author(s):  
L Mohankrishna ◽  
◽  
P. J. Reddy ◽  
B. P Reddy. ◽  
P. Navya
Keyword(s):  
Amphotericin B ◽  
Mobile Phase ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Phase Combination ◽  
Hplc Method Development

A sensitive and precise HPLC procedure has been developed for the assay of amphotericin B in bulk samples and pharmaceutical formulations by using a C18 column [Kromosil, C18, (5 µm, 4.6mm x 250 mm; Make. Waters)], and mobile phase combination is 1% formic acid in water and acetonitrile in ratio of 45:55 V/V. The procedure has been validated as per the ICH guidelines. The λmax of detection was fixed at 407 nm, so that there was less interference from mobile phase with highest sensitivity according to UV analysis. Calibration plots were linear in the range of 10-100 µg/mL and the LOD and LOQ were 0.02 µg/mL and 0.06 µg/mL respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of amphotericin B in different formulations.

scholarly journals Simultaneous determination of clobutinol hydrochloride and doxylamine succinate from syrups by RP HPLC using a new stationary phase containing embedded urea polar groups

2012 ◽  
Vol 48 (2) ◽  
pp. 315-323 ◽  
Author(s):  
Paulo Cesar Pires Rosa ◽  
Isabel Cristina Sales Fontes Jardim
Keyword(s):  
Stationary Phase ◽  
Simultaneous Determination ◽  
Reversed Phase ◽  
Hplc Method ◽  
Array Detector ◽  
Polar Groups ◽  
Ich Guidelines ◽  
Relative Standard ◽  
New Stationary Phase

A new, simple, fast, reproducible and sensitive reversed phase HPLC method, using a new stationary phase containing embedded urea polar groups, has been developed and validated for the simultaneous determination of clobutinol hydrochloride (CLO) and doxylamine succinate (DOX) in syrups. The determination was carried out on a C8 urea column (125 mm x 3.9 mm i.d., 5 µm particle size) synthetized at the Liquid Chomatography Laboratory (LabCrom) of the Chemistry Institute of Unicamp. The mobile phase consisted of a mixture of acetonitrile:methanol:phosphate buffer (pH 2.5) in the gradient mode. The diode array detector (DAD) was operated at 230 nm for CLO and 262 nm for DOX. The method showed adequate precision, with relative standard deviations (RSD) less than 1%. The presence of the excipients did not interfere in the results of the analysis. Accuracy was determined by adding standards of the drugs to a placebo and good recovery values were obtained. The analytical curves were linear (r² 0.9999 for CLO and 0.9998 for DOX) over a wide concentration range (2.4-336 µg mL-1 for CLO and 2.3-63 µg mL-1 for DOX). The solutions were stable for at least 72 hours at room temperature. The criteria for validation using the ICH guidelines were fulfilled.

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