scholarly journals The simultaneous spectrophotometric determination of trimazolin and phenylephrine hydrochloride in nasal preparations

2008 ◽  
Vol 14 (4) ◽  
pp. 261-264 ◽  
Author(s):  
Ivana Savic ◽  
Goran Nikolic ◽  
Ivan Savic ◽  
Vladimir Bankovic
Keyword(s):  
Spectrophotometric Determination ◽  
Pharmaceutical Formulations ◽  
Active Components ◽  
Phenylephrine Hydrochloride ◽  
Drug Substances ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Relative Standard ◽  
High Degree

This paper presents the experimental results for the simultaneous spectrophotometric determination of two active components in nasal solutions. The resolution of two-component mixtures of timazolin and phenylephrine has been accomplished by using partial least-squares. The method comprised of the absorptivity measurement in a nasal solution at wavelengths of 265 and 272 nm, respectively. Notwithstanding the presence of two components and their high degree of spectral overlap, they have been determined simultaneously with high accuracy and precision, with no interference, rapidly and without resorting to extraction procedures using non aqueous solvents. This method was tested and validated for various parameters according to ICH guidelines. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2 %), while being simple, cheap and less time consuming. The method was applied for the analysis of these drug substances in their commercial pharmaceutical formulations.

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 Enantiomeric Separation of Colchicine and Lacosamide by Nano-LC. Quantitative Analysis in Pharmaceutical Formulations

Separations ◽  
2020 ◽  
Vol 7 (4) ◽  
pp. 55
Author(s):  
Natalia Casado ◽  
Zhengjin Jiang ◽  
María Ángeles García ◽  
María Luisa Marina
Keyword(s):  
Chiral Stationary Phase ◽  
Capillary Column ◽  
Pharmaceutical Formulations ◽  
Enantiomeric Separation ◽  
Chiral Drugs ◽  
Analytical Methodology ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Nano Liquid Chromatography

A chiral analytical methodology was developed by nano-liquid chromatography (nano-LC) enabling the enantiomeric separation of two chiral drugs, lacosamide (novel antiepileptic drug) and colchicine (antiuremic drug), commercialized as pure enantiomers. A capillary column lab-packed with an amylose tris(3,5-dimethylphenylcarbamate) chiral stationary phase was used in a lab-assembled nano-LC system. Lacosamide and colchicine enantiomers were separated in less than 8.0 and 9.0 min, respectively, with resolution values of 1.6 and 2.3, using 20 nL of sample and 1.8 µL of mobile phase per analysis. The analytical characteristics of the proposed methodology were evaluated according to the International Council for Harmonisation (ICH) guidelines, showing good analytical performance with good recoveries (97–98% and 100–103%) and precision values (relative standard deviation (RSD) <10.5 and <3.0%) for lacosamide and colchicine enantiomers, respectively. LODs were 1.7 and 2.0 µg/mL for (S)- and (R)-lacosamide, respectively, and 1.0 µg/mL for both colchicine enantiomers. Additionally, the developed methodology enabled to detect a 0.1% of the enantiomeric impurities, fulfilling the ICH regulation requirements. The method was applied to the determination of lacosamide and colchicine enantiomers in different pharmaceutical formulations to ensure their quality control. The content of the enantiomeric impurities was below a 0.1% and the amount of (R)-lacosamide and (S)-colchicine agreed with their labeled contents.

scholarly journals H-point Standard Addition Method for the Simultaneous Spectrophotometric Determination of Captopril and Hydrochlorothiazide in Pharmaceutical Formulations

2021 ◽  
pp. 77-85
Keyword(s):  
Spectrophotometric Determination ◽  
Standard Addition ◽  
Pharmaceutical Formulations ◽  
Standard Addition Method ◽  
Addition Method ◽  
Real Samples ◽  
Relative Standard ◽  
Recovery Percentage ◽  
Precision And Accuracy

Simultaneous spectrophotometric determination of captopril and hydro-chlorothiazide in pharmaceutical formulations by the H-point standard addition method (HPSAM) is described. Absorbance at 211.5 and 230.3 nm was monitored upon the addition of standard solutions of captopril. The results showed that in prepared mixtures, captopril and hydrochlorothiazide can be determined simultaneously at concentration ratios varying from 1.0:0.8 to 2.5:1.5 μg/mL, respectively. Percentage recovery was found to be 95.33–104.37% for captopril and 96.8–105% for hydrochlorothiazide, with a relative standard deviation (RSD) of 2.46%. The method was successfully used to evaluate the antihypertensive captopril drug in a binary combination of hydrochlorothiazide in real samples with high precision and accuracy within the recovery percentage.

scholarly journals Rapid, Simple, and Sensitive Spectrofluorimetric Method for the Estimation of Ganciclovir in Bulk and Pharmaceutical Formulations

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Garima Balwani ◽  
Emil Joseph ◽  
Satish Reddi ◽  
Vibhu Nagpal ◽  
Ranendra N. Saha
Keyword(s):  
Standard Deviation ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Calibration Graph ◽  
Limit Of Quantification ◽  
Average Percentage ◽  
Ich Guidelines ◽  
Spectrofluorimetric Method ◽  
Relative Standard

A new, simple, rapid, sensitive, accurate, and affordable spectrofluorimetric method was developed and validated for the estimation of ganciclovir in bulk as well as in marketed formulations. The method was based on measuring the native fluorescence of ganciclovir in 0.2 M hydrochloric acid buffer of pH 1.2 at 374 nm after excitation at 257 nm. The calibration graph was found to be rectilinear in the concentration range of 0.25–2.00 μg mL−1. The limit of quantification and limit of detection were found to be 0.029 μg mL−1and 0.010μg mL−1, respectively. The method was fully validated for various parameters according to ICH guidelines. The results demonstrated that the procedure is accurate, precise, and reproducible (relative standard deviation <2%) and can be successfully applied for the determination of ganciclovir in its commercial capsules with average percentage recovery of 101.31 ± 0.90.

scholarly journals Simultaneous Determination of Piracetam and Citicoline in Combination Drug Products by Rp-Hplc Method

2021 ◽  
pp. 171-185
Author(s):  
Meka. Srinivasa Rao ◽  
K. Rambabu
Keyword(s):  
Hplc Method ◽  
Simultaneous Estimation ◽  
Combination Drug ◽  
Drug Products ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
System Suitability ◽  
Relative Standard

In this paper a simple, accurate and precise RP-HPLC method for the simultaneous. Estimation of piracetam and citicoline in synthetic mixtures has been developed and validated. Separation of drugs was carried out using buffer and Acetonitryle with proportion of 60:40 %v/v as mobile phase at 5 min. run time and 265nm. The Rt value for piracetam and citicoline was found to be 3.158 and 5.196 min respectively. The developed method has been validated for linearity, accuracy and precision, LOD, LOQ, and system suitability according to ICH guidelines. The low values of LOD and LOQ illustrate that the developed method was sensitive, accurate, and precise as it can detected and quantify with very low concentration. The low % RSD values below 2 indicate that the method is precise. The above validation studies revealed the method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of piracetam and citicoline in combined dose products.

scholarly journals A Sensitive UV Spectrophotometric Method for the Determination of Gabapentin

2009 ◽  
Vol 6 (s1) ◽  
pp. S163-S170 ◽  
Author(s):  
R. Singh Gujral ◽  
S. Manirul Haque ◽  
P. Shanker
Keyword(s):  
Spectrophotometric Method ◽  
Good Accuracy ◽  
Limit Of Detection ◽  
Low Cost ◽  
Pharmaceutical Formulations ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Precision Limit

An accurate and validated spectrophotometric method was developed for the determination of gabapentin. This is simple, sensitive and low cost UV spectrophotometric method. The method is based on the direct measurement of the native absorbance of the drug. The detection was done at 210 nm. The method was linear in the range of 0.25 - 3.5 µ g/mL with correlation coefficient of 0.9999. It is validated according to the ICH guidelines with respect to linearity, selectivity, accuracy and precision, limit of quantitation and limit of detection. The method has been applied to assess gabapentin in pharmaceutical formulations with good accuracy and precision and relatively free of interference from coexisting substances.

scholarly journals Spectrophotometric Determination of Some Antihistaminic Drugs Using 7,7,8,8-Tetracyanoquinodimethane (TCNQ)

2006 ◽  
Vol 89 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Amr M Badawey ◽  
Samah S Abbas ◽  
Hayam M Loutfy
Keyword(s):  
Spectrophotometric Determination ◽  
Spectrophotometric Method ◽  
Good Accuracy ◽  
Pharmaceutical Formulations ◽  
European Pharmacopoeia ◽  
Accuracy And Precision ◽  
Antihistaminic Drugs ◽  
Assay Conditions ◽  
Sensitive Spectrophotometric Method

Abstract A simple and sensitive spectrophotometric method is suggested for analysis of 3 antihistaminic drugs, acrivastine (I), mequitazine (II), and dimethindene maleate (III). The method is based on reaction of the drugs with 7,7,8,8-tetracyanoquinodimethane (TCNQ) in acetonitrile to form highly stable colored products that are measured at 750, 766, and 844 nm for I and II, and 480 and 618 nm for III. Beer's law is obeyed in the ranges of 560 g/mL for I, 550 g/mL for II, and 1070 g/mL for III. The optimum assay conditions and their applicability to the determination of the cited drugs in pharmaceutical formulations are described. The method is statistically analyzed as compared with the European Pharmacopoeia (2001) method for the analysis of dimethindene maleate and reference methods for acrivastine and mequitazine drugs revealing good accuracy and precision.

scholarly journals Simultaneous Spectrophotometric Determination of Paracetamol and Salicylamide in Human Serum and Pharmaceutical Formulations by a Differential Kinetic Method

2005 ◽  
Vol 88 (6) ◽  
pp. 1695-1701 ◽  
Author(s):  
Ali Reza Zarei ◽  
Abbas Afkhami ◽  
Nahid Sarlak
Keyword(s):  
Human Serum ◽  
Simultaneous Determination ◽  
Spectrophotometric Determination ◽  
Oxidation Reaction ◽  
Kinetic Method ◽  
Pharmaceutical Formulations ◽  
The Other ◽  
Relative Standard ◽  
Standard Deviations

Abstract A rapid, simple, and sensitive differential kinetic method is presented for the determinations of acetaminophen (also known as paracetamol) and salicylamide. The method is based on their oxidation reaction by Fe3+ ion in the presence of 1,10-phenanthroline as indicator. The reactions can be monitored spectrophotometrically by measuring the increase in the absorbance of the solution at 510 nm. Two times were selected one in which only paracetamol is oxidized by Fe3+ ion and the other in which both drugs are oxidized by Fe3+ ion. The data were evaluated by the proportional equations method. The method allowed the simultaneous determination of paracetamol and salicylamide at concentrations between 0.5–20 and 1–40 μg/mL with relative standard deviations of 3.47 and 2.58%, respectively. The method was applied to the simultaneous determination of paracetamol and salicylamide in human serum and pharmaceutical formulations.

scholarly journals Determination of Phenylephrine Hydrochloride by Flow Injection Analysis with Chemiluminescence Detection

2001 ◽  
Vol 84 (1) ◽  
pp. 13-18 ◽  
Author(s):  
Yolanda Fuster Mestre ◽  
Luis Lahuerta Zamora ◽  
José Martínez Calatayud
Keyword(s):  
Flow Injection ◽  
Flow Injection Analysis ◽  
Pharmaceutical Formulations ◽  
Calibration Graph ◽  
Chemiluminescence Detection ◽  
Phenylephrine Hydrochloride ◽  
Sulfuric Acid Medium ◽  
Sample Throughput ◽  
Relative Standard

Abstract A new method is proposed for the determination of phenylephrine hydrochloride by flow injection analysis with direct chemiluminescence detection. The method is based on the oxidation of the drug by potassium permanganate in sulfuric acid medium at 80°C. The calibration graph is linear over the range 0.03–8 ppm phenylephrine hydrochloride, with a relative standard deviation (n = 51, 0.5 ppm) of 1.1% and sample throughput of 134/h. The influence of 38 different foreign compounds was tested, and the method was applied to the determination of phenylephrine hydrochloride in 8 different pharmaceutical formulations.

Development of Validated UV Spectrophotometric Method for Assay of Ozagrel and its Pharmaceutical Formulations

2018 ◽  
pp. 69-77 ◽  
Author(s):  
Vishal N Kushare ◽  
Sachin S Kushare ◽  
Sagar V Ghotekar
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Routine Practice ◽  
Quantitation Limit ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Standard Values ◽  
Bulk Drug

UV Spectrophotometric method was developed and validated for the quantitative determination of Ozagrel in bulk drug and in pharmaceutical formulations. Ozagrel shows the maximum absorbance at 270 nm. Ozagrel follows Beer’s law in the concentration range of 1.0-10.0 µg/ml (r = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.4629 and 1.4027 µg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Ozagrel in assay of bulk drug and pharmaceutical formulations.

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