scholarly journals Development and Validation of a UV-Spectrophotometric Method for Determination of Vildagliptin and Linagliptin in Bulk and Pharmaceutical Dosage Forms

2015 ◽  
Vol 18 (2) ◽  
pp. 163-168 ◽  
Author(s):  
Sujan Banik ◽  
Palash Karmakar ◽  
Md Anowar Hossain Miah
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Correlation Coefficients ◽  
Pharmaceutical Journal ◽  
Dosage Forms ◽  
Limit Of Quantification ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Forms ◽  
Tablet Dosage

The present study was undertaken to develop a spectrophotometric method for determination of vildagliptin and Linagliptin in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate and precise UVspectrophotometric method for the assay of vildagliptin and linagliptin in bulk and marketed tablet dosage forms. The validation of the developed method was carried out according to ICH guidelines with respect to linearity, precision, accuracy, specificity, limit of detection and limit of quantification. Calibration curves were obtained in the concentration range of 8-32 ?g/ml for vildagliptin and 5-25 ?g/ml for linagliptin with good correlation coefficients (r=0.999). The precisions of the new method for both drugs were less than the maximum allowable limit (%RSD < 2.0) specified by the USP, ICH and FDA. Therefore, the method was found to be an accurate, reproducible and sensitive for analysis of vildagliptin and linagliptin in pharmaceutical dosage forms.Bangladesh Pharmaceutical Journal 18(2): 163-168, 2015

scholarly journals Spectrophotometric Method for the Determination of Drugs Containing Phenol Group by Using 2, 4- Dinitrophenylhydrazine

2010 ◽  
Vol 7 (2) ◽  
pp. 395-402
Author(s):  
Padmarajaiah Nagaraja ◽  
Ashwinee Kumar Shrestha
Keyword(s):  
Standard Deviation ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Dosage Forms ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Phenolic Drugs

A spectrophotometric method has been proposed for the determination of four phenolic drugs; salbutamol, ritodrine, amoxicillin and isoxsuprine. The method is based on the oxidation of 2, 4- dinitrophenyl-hydrazine and coupling of the oxidized product with drugs to give intensely colored chromogen. Under the proposed optimum condition, beer’s law was obeyed in the concentration range of 2.5-17, 2-29, 4-33 and 5-30 μg/mL for salbutamol, ritodrine, amoxicillin and isoxsuprine respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.2, 0.83, 0.09, 0.84 μg/mL and 0.66, 2.79, 0.3 and 2.81 μg/mL in the same order. No interference was observed from common pharmaceutical adjuvants. The ringbom plots and low relative standard deviation assert the applicability of this method. The suggested method was further applied for the determinations of drugs in commercial pharmaceutical dosage forms, which was compared statistically with reference methods by means oft- test andF- test and were found not to differ significantly at 95% confidence level. The procedure is characterized by its simplicity with accuracy and precision.

scholarly journals Development and Validation of UV Spectrophotometric Method For Determination of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Forms

2017 ◽  
Vol 6 (5) ◽  
pp. 196-199 ◽  
Author(s):  
Shahinaz Mohammed ◽  
Mohammed Adam ◽  
Shaza Shantier
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Recovery Percentage ◽  
Development And Validation ◽  
Tablet Dosage

In this study a simple, accurate and precise UV- spectrophotometric method was developed for the estimation of bisoprolol fumarate (BF) in bulk and tablet dosage form. The method was based on measurement of absorbance of BF aqueous solution at 271nm. Validation was conducted in accordance to ICH guidelines. The calibration curve was linear in the concentration range 5-25 µg/mL with correlation coefficient not less than 0.9986. The limit of detection and limit of quantification were 0.22 μg/ml and 0.66 μg/ml, respectively. Intraday and intermediate precision of the developed method were reflected by the low RSD% values (1.19 and 0.854, respectively). The recovery percentage was 105.0 ± 1.3%, n=3. The proposed method was applied for the assay of BF in three different brands

scholarly journals A Simple and Rapid RP-HPLC Method for the Estimation of Nevirapine in Bulk and Pharmaceutical Dosage Forms

2008 ◽  
Vol 5 (s2) ◽  
pp. 1081-1086
Author(s):  
Palaniappan Mohanraj ◽  
Deb Kumar Sarkar ◽  
Tirthankar Choudhury ◽  
Karunakaran Gauthaman
Keyword(s):  
Limit Of Detection ◽  
Dosage Forms ◽  
Hplc Method ◽  
Detector Response ◽  
Reverse Phase Hplc ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Accuracy And Precision ◽  
Tablet Dosage

A reverse phase HPLC method is described for the determination of nevirapine in tablet dosage forms. Chromatography was carried on an ODS column using a mixture of methanol and water (89:11 v/v) as the mobile phase at a flow rate of 1 mL/min with detection at 284 nm. The retention time of the drug was 3.22 min. The detector response was linear in the concentration of 25-200 mcg/mL. The limit of detection and limit of quantification was 0.004 and 0.0121 mcg/mL respectively. The percentage assay of nevirapine was 99.52%. The method was validated by determining its sensitivity, accuracy and precision. The proposed method is simple, economical, fast, accurate and precise and hence can be applied for routine quality control of nevirapine in bulk and tablet dosage forms.

scholarly journals Spectrophotometric determination of Phenylephrine hydrochloride and Salbutamol sulphate drugs in pharmaceutical preparations using diazotized Metoclopramide hydrochloride

2015 ◽  
Vol 12 (1) ◽  
pp. 167-177 ◽  
Author(s):  
Baghdad Science Journal
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Preparations ◽  
Correlation Coefficients ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Salbutamol Sulphate ◽  
Phenylephrine Hydrochloride ◽  
Relative Standard ◽  
Metoclopramide Hydrochloride

A spectrophotometric method has been proposed for the determination of two drugs containing phenol group [phenylephrine hydrochloride (PHP) and salbutamol sulphate (SLB)] in pharmaceutical dosage forms. The method is based on the diazotization reaction of metoclopramide hydrochloride (MCP) and coupling of the diazotized reagent with drugs in alkaline medium to give intense orange colored product (?max at 470 nm for each of PHP and SLB). Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. Under the proposed optimum condition, Beer’s law was obeyed in the concentration range of 1-32 and 1-14 ?g mL-1 for PHP and SLB, respectively. The limit of detection (LOD) and limit of quantification (LOQ) for each of PHP and SLB were 0.60, 0.52 ?g mL-1 and 2.02, 1.72 ?g mL-1, respectively. No interference was observed from common excipients present in pharmaceutical preparations. The good correlation coefficients and low relative standard deviation assert the applicability of this method. The suggested method was further applied for the determinations of drugs in commercial pharmaceutical preparations, which was compared statistically with reference methods by means of t- test and F- test and were found not to differ significantly at 95% confidence level. The procedure was characterized by its simplicity with accuracy and precision.

SIMULTANEOUS ESTIMATION AND VALIDATION OF RAMIPRIL AND TELMISARTAN BY UV SPECTROPHOTOMETRY

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (09) ◽  
pp. 31-35
Author(s):  
R Rambabu ◽  
◽  
S Vidyadhara ◽  
J Subbarao
Keyword(s):  
Spectrophotometric Method ◽  
Correlation Coefficients ◽  
Simultaneous Equation ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Sensitive Spectrophotometric Method

A simple and sensitive spectrophotometric method for the determination of ramipril and telmisartan in pharmaceutical dosage forms has been developed. The absorption maxima were found at 220nm for ramipril and 297nm for telmisartan using 0.1N NaOH as solvent. Beer’s law was obeyed for both the drugs in the concentration range of 2-10μg/ml with correlation coefficients 0.999 for both ramipril and telmisartan. The limits of detection for ramipril and telmisartan were found to be 0.142 and 0.405μg/mL respectively and the limits of quantitation were 0.43 and 1.22μg/mL. Accuracy of the method was verified by performing recovery studies using simultaneous equation method and found to be 98.33 to 99.54%w/w for ramipril and 99.36 to 99.82 %w/w for telmisartan. %RSD of repeatability and intermediate precision studies were found to be <2 for both the drugs. Ruggedness of the method was checked by changing analyst worked and instrument used. In both the cases, the %RSD was found to be less than 2.

scholarly journals Validated TLC-densitometry method for determination of cetirizine dihydrochloride in tablet dosage form

2013 ◽  
Vol 3 (1) ◽  
pp. 208-210
Author(s):  
Nia Kristiningrum ◽  
Ellsy Novita Martyanti
Keyword(s):  
Mobile Phase ◽  
Limit Of Detection ◽  
Pharmaceutical Journal ◽  
Limit Of Quantification ◽  
Quality Control Testing ◽  
Relative Standard ◽  
Tablet Formulations ◽  
Tablet Dosage ◽  
Chloroform Methanol

A rapid, reproducible and accurate TLC method was developed for the determination of Cetirizine Dihydrochloride in tablet. The analytes were dissolved with ethanol 70% and chromatographed on silica Gel GF 254 TLC plate using chloroform : methanol : ethyl acetate in the ratio of 2 : 7 : 3 (v/v) as mobile phase. Quantitative analysis was done through densitometric measurement at wavelength 234 nm. Method was found linear over the concentration range of 400 – 1600 ng/spot with the correlation coefficient of 0.996. Specificity showed calculation of purity and identity more than 0.99. The limit of detection (LOD) and the limit of quantification (LOQ) of the method were 75.54 and 226.64 ng/spot. The relative standard deviation of this method was 0.86% whereas the means of the recovery data was 100.54 ± 0.11%. The proposed method has been applied to the determination of Cetirizine Dihydrochloride in commercial tablet formulations and the result were 96.97 ± 0.86 % for brand A and 100.57 ± 1.17 % for brand B. The developed method was successfully used for the assay of Cetirizine Dihydrochloride. This method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.DOI: http://dx.doi.org/10.3329/icpj.v3i1.17294 International Current Pharmaceutical Journal, December 2013, 3(1): 208-210

scholarly journals DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FEBUXOSTAT FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTS IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (9) ◽  
pp. 115
Author(s):  
Jaspreet Kaur ◽  
Daljit Kaur ◽  
Sukhmeet Singh
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

Objective: A simple, accurate, and selective ultraviolet-spectrophotometric method has been developed for the estimation of febuxostat in the bulk and pharmaceutical dosage forms.Method: The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The developed method was validated statistically with respect to linearity, range, precision, accuracy, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and recovery. Specificity of the method was demonstrated by applying different stressed conditions to drug samples such as acid hydrolysis, alkaline hydrolysis, oxidative, photolytic, and thermal degradation.Results: The study was conducted using phosphate buffer pH 6.8 and λmax was found to be 312 nm. Standard plot having a concentration range of 1–10 μg/ml showed a good linear relationship with R2=0.999. The LOD and LOQ were found to be 0.118 μg/ml and 0.595 μg/ml, respectively. Recovery and percentage relative standard deviations were found to be 100.157±0.332% and <2%, respectively.Conclusion: Proposed method was successfully applicable to the pharmaceutical formulations containing febuxostat. Thus, the developed method is found to be simple, sensitive, accurate, precise, reproducible, and economical for the determination of febuxostat in pharmaceutical dosage forms.

HPTLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CHLORTHALIDONE AND IRBESARTAN IN COMBINED TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (07) ◽  
pp. 46-52
Author(s):  
P Kalaiselvi ◽  
◽  
K. G. Lalitha
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Ammonia Solution ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Tablet Dosage ◽  
Hptlc Method

A simple, accurate and rapid high performance thin layer chromatography (HPTLC)-densitometry method was developed for separation and determination of chlorthalidone (CHL) and irbesartan (IBS) in pharmaceutical dosage forms. The compounds were separated on silica gel 60 GF254, HPTLC plates using mobile phase of toluene: ethyl acetate: acetonitrile: methanol: ammonia solution (25%) [5:2:2:1:0.2 v/v/v/v] as compact spots at Rf of 0.57 for chlorthalidone and Rf of 0.36 for irbesartan. Densitometric detection was performed at 254 nm. The method was validated in terms of linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves were linear in the range of 12.5-75 ng/spot for CHL and 150-900ng/spot for IBS. For CHL recovery varied in range of 99.26-101.25% and for IBS recovery varied in range of 99.76-100.40%. The LOD was found 1.33 and 11.34 ng/spot for CHL and IBS respectively. The LOQ was found 4.03 and 14.37 ng /spot for CHL and IBS respectively. It was observed that the proposed HPTLC method could be used for efficient analysis of the CHL and IBS in combined tablet dosage forms.

scholarly journals Analytical Spectrometric Study For Determining Dapagliflozin Propanediol Monohydrate Individually Or In Presence Of Metformin Hydrochloride In Tablets Formulation

2020 ◽  
Vol 17 ◽  
pp. 80-87
Author(s):  
SAAD ANTAKLI ◽  
Raghad Kabbani ◽  
And Rama Labban
Keyword(s):  
Regression Analysis ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Correlation Coefficients ◽  
Metformin Hydrochloride ◽  
Spectrometric Study ◽  
Limit Of Quantification ◽  
First Derivative ◽  
Linearity Range

First simple spectrophotometric method was developed and applied to determine Dapagliflozin Propanediol  Monohydrate by Zero Spectrophotometry and First Derivative Spectrophotometric method for determining of Dapagliflozin Propanediol Monohydrate (DAPA) in the presence of Metformin Hydrochloride (MET). Zero spectrophotometric (ZS) was applied for the determination of (DAPA) at 223.5 nm. Linearity range was (2.61– 31.23) µg/mL. Regression analysis showed a good correlation coefficients R2 = 0.9989. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.569 µg/mL and 1.724 µg/mL, respectively. Derivative spectrophotometric (1DS) was applied for the determination of (DAPA) in the presence (MET). (DAPA) was determined at 233 nm (1D233).  Linearity ranges were (5.21 – 41.64) µg/mL for (DAPA). Regression analysis showed a good correlation coefficients R2 = 0.9994. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.732 µg/mL and 2.218 µg/mL for (DAPA). The proposed Zero spectrophotometry method was applied to analysis individual (DAPA), and the derivative (1D233) method was applied to analysis (DAPA) individually or with (MET) combination in Syrian trademark drugs.

DEVELOPMENT AND VALIDATION OF NOVEL STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF CINACALCET HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (12) ◽  
pp. 31-36
Author(s):  
N Mallikarjuna Rao ◽  
◽  
D. Gowrisankar
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Spectroscopic Method ◽  
Dosage Forms ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Limit Of Quantitation ◽  
Cinacalcet Hydrochloride ◽  
Tablet Dosage

A novel stability indicating UV spectrophotometric method for the quantitative determination of cinacalcet hydrochloride, a calcimimetic, in bulk and tablet dosage forms was developed in the present work. The parameters linearity, precision, accuracy, limit of detection and limit of quantitation were studied according to International Conference on Harmonization guidelines. UV spectroscopic determination was carried out at an absorption maximum of 281 nm using methanol as solvent. In the UV spectroscopic method, linearity over the concentration range of cinacalcet hydrochloride was found to be 15-35 μg/mL with a correlation coefficient of 0.9992. Results of the analysis were validated statistically and by recovery studies. Forced degradation studies were conducted under various conditions. The proposed method is simple, rapid, precise and accurate and can be used for the reliable quantitation of cinacalcet hydrochloride in commercial pharmaceutical dosage forms.

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