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

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.

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Development and Validation of a RP-HPLC Method for Quantitative Analysis of Linagliptin in Bulk and Dosage Forms

Dhaka University Journal of Pharmaceutical Sciences ◽

10.3329/dujps.v17i2.39173 ◽

2018 ◽

Vol 17 (2) ◽

pp. 175-182

Author(s):

Joy Chandra Rajbangshi ◽

Md Mahbubul Alam ◽

Md Shahadat Hossain ◽

Md Samiul Islam ◽

Abu Shara Shamsur Rouf

Keyword(s):

Limit Of Detection ◽

Dosage Forms ◽

Hplc Method ◽

Pharmaceutical Dosage Forms ◽

Rp Hplc ◽

System Suitability ◽

Relative Standard ◽

Limit Of Quantitation ◽

Precision Limit ◽

Development And Validation

This research was aimed to establish a versatile, sensitive, rapid and validated RP-HPLC method to analyze linagliptin in bulk as well as in pharmaceutical dosage forms. Liquid chromatography was performed on HPLC system and 20μl of samples were injected into a C18 column (150 x 4.6 mm i.d., 5μm particle size) and the eluents were monitored through a PDA detector at 239 nm. An isocratic method with a flow rate of 1 ml/min was used to elute the compounds with a mobile phase comprised of 70:30 v/v mixture of phosphate buffer (pH 6.8±0.2) and acetonitrile. The retention time of the compound was found to be 2.8 minutes. According to the ICH Q2(R1) guidelines, the method was validated by establishing several analytical parameters such as system suitability, specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness and robustness to assay linagliptin. The method showed good linearity (R2 = 0.9981) over the concentration ranges of 40 – 60 μg/ml with a recovery between 99.48% ± 0.38% RSD to 100.22% ± 0.011% RSD, whereas the LOD and LOQ values were 0.05 μg/ml and 0.15 μg/ml, respectively. The relative standard deviation (% RSD) for inter-day and intra-day precision was not more than 2.0%. Hence, the proposed method can be applied accurately for research and routine analysis of linagliptin in bulk as well as different pharmaceutical dosage forms. Dhaka Univ. J. Pharm. Sci. 17(2): 175-182, 2018 (December)

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Development and Validation of a Spectrophotometric Method for Quantification and Dissolution Studies of Glimepiride in Tablets

E-Journal of Chemistry ◽

10.1155/2012/856130 ◽

2012 ◽

Vol 9 (2) ◽

pp. 993-998

Author(s):

Madhusudhanareddy Induri ◽

Bhagavan Raju M. ◽

Rajendra Prasad Y. ◽

Pavankumar Reddy K.

Keyword(s):

Quantitative Determination ◽

Spectrophotometric Method ◽

Analytical Method ◽

Limit Of Detection ◽

Pharmaceutical Formulations ◽

Spectrophotometric Methods ◽

Dissolution Studies ◽

Limit Of Quantitation ◽

Development And Validation

The objective of present study was to develop and validate an analytical method for quantitative determination and dissolution studies of glimepiride in tablets. The glimepiride shows absorption maxima at 225 nm and obeyed Beer's law in the range of 6.0 – 14.0 µg/mL. The limit of detection and limit of quantitation were 0.06, and 0.17 µg/mL respectively. Percentage recovery of glimepiride for the proposed method ranged from 99.32 to 100.98% indicating no interference of the tablet excipients. It was concluded that the proposed method is simple, easy to apply, economical and used as an alternative to the existing spectrophotometric and non-spectrophotometric methods for the routine analysis of glimepiride in pharmaceutical formulations andin vitrodissolution studies.

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

E-Journal of Chemistry ◽

10.1155/2010/328061 ◽

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.

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DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF HYDROQUINONE IN BULK, MARKETED CREAM AND PREAPARED NLC FORMULATION

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2017v9i5.20467 ◽

2017 ◽

Vol 9 (5) ◽

pp. 102

Author(s):

Sukhjinder Kaur ◽

Taranjit Kaur ◽

Gurdeep Kaur ◽

Shivani Verma

Keyword(s):

Spectrophotometric Method ◽

Limit Of Detection ◽

Pharmaceutical Formulations ◽

Pure Form ◽

Nanostructured Lipid Carrier ◽

Limit Of Quantification ◽

Double Beam ◽

Uv Visible ◽

Development And Validation

Objective: The aim of the present work was to develop a simple, rapid, accurate and economical UV-visible spectrophotometric method for the determination of hydroquinone (HQ) in its pure form, marketed formulation as well as in the prepared nanostructured lipid carrier (NLC) systems and to validate the developed method.Methods: HQ was estimated at UV maxima of 289.6 nm in pH 5.5 phosphate buffer using UV-Visible double beam spectrophotometer. Following the guidelines of the International Conference on Harmonization (ICH), the method was validated for various analytical parameters like linearity, precision, and accuracy robustness, ruggedness, limit of detection, quantification limit, and formulation analysis.Results: The obtained results of the analysis were validated statistically. Recovery studies were performed to confirm the accuracy of the proposed method. In the developed method, linearity over the concentration range of 5-40 μg/ml of HQ was observed with the correlation coefficient of 0.998 and found in good agreement with Beer Lambert’s law. The precision (intra-day and inter-day) of the method was found within official RCD limits (RSD<2%).Conclusion: The sensitivity of the method was assessed by determining the limit of detection and limit of quantification. It could be concluded from the results obtained that the purposed method for estimation of HQ in pure form, in the marketed ointment and in the prepared NLC-formulation was simple, rapid, accurate, precise and economical. It can be used successfully in the quality control of pharmaceutical formulations and for the routine laboratory analysis.

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Development and validation of spectrophotometric method for phenylephrine hydrochloride estimation in nasal drops formulations

Macedonian Journal of Chemistry and Chemical Engineering ◽

10.20450/mjcce.2008.235 ◽

2008 ◽

Vol 27 (2) ◽

pp. 149 ◽

Cited By ~ 3

Author(s):

Ivana Savić ◽

Goran Nikolić ◽

Vladimir Banković

Keyword(s):

Standard Deviation ◽

Sodium Hydroxide ◽

Relative Standard Deviation ◽

Spectrophotometric Method ◽

Molar Absorptivity ◽

Dosage Forms ◽

Phenylephrine Hydrochloride ◽

Relative Standard ◽

Development And Validation

Simple, accurate and reproducible UV-spectrophotometric method was developed and validated for the estimation of phenylephrine hydrochloride in pharmaceutical nasal drops formulations. Phenylephrine hydrochloride was estimated at 291 nm in 1 mol⋅dm-3 sodium hydroxide (pH 13.5). Beer’s law was obeyed in the concentration range of 10–100 μg⋅cm−3 (r2 = 0.9990) in the sodium hydroxide medium. The apparent molar absorptivity was found to be 1.63×103 dm3⋅mol−1⋅cm−1. The method was tested and validated for various parameters according to the ICH (International Conference on Harmonization) guidelines. The detection and quantitation limits were found to be 0.892 and 2.969 μg⋅cm−3, respectively. The proposed method was successfully applied for the determination of phenylephrine hydrochloride in pharmaceutical nasal drops formulations. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 1 %), while being simple, cheap and less time consuming, and hence can be suitably applied for the estimation of phenylephrine hydrochloride in different dosage forms.

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VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2020v12i2.37491 ◽

2020 ◽

pp. 63-67

Author(s):

SMITA KUMBHAR ◽

VINOD MATOLE ◽

YOGESH THORAT ◽

ANITA SHEGAONKAR ◽

AVINASH HOSMANI

Keyword(s):

Spectrophotometric Method ◽

Method Development ◽

Pharmaceutical Formulations ◽

Uv Spectrum ◽

Colored Complex ◽

Pharmaceutical Dosage Forms ◽

Highly Sensitive ◽

Method Development And Validation ◽

Development And Validation

Objective: A new, simple, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the determination of Imatinib in pharmaceutical formulations with alizarin. Methods: The method is based on formation of yellow-colored complex. The UV spectrum of Imatinib in methanol showed λ max at 431 nm. Beer’s law is valid in the concentration range of 10-70 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-70 μg/ml with regression equation y =0.013x-0.017 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (4.3μg/ml) and LOQ (13.07μg/ml). Conclusion: Based on results the proposed method can be successfully applied for the assay of Imatinib in various pharmaceutical dosage forms.

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Determination of metoprolol in pure and pharmaceutical dosage forms by spectrofluorometry and high performance liquid chromatography

Chemical Industry and Chemical Engineering Quarterly ◽

10.2298/ciceq100422047y ◽

2011 ◽

Vol 17 (1) ◽

pp. 25-31 ◽

Cited By ~ 5

Author(s):

Bilal Yilmaz ◽

Kadem Meral ◽

Ali Asci ◽

Yavuz Organer

Keyword(s):

High Performance Liquid Chromatography ◽

Liquid Chromatography ◽

High Performance ◽

Solvent System ◽

Dosage Forms ◽

Content Uniformity ◽

Pharmaceutical Dosage Forms ◽

Relative Standard ◽

Limit Of Quantitation

In this study, a new and rapid spectrofluorometry and high performance liquid chromatography (HPLC) methods were developed for determination of metoprolol in pure and pharmaceutical dosage forms. The solvent system, wavelength of detection and chromatographic conditions were optimized in order to maximize the sensitivity of both the proposed methods. The linearity was established over the concentration range of 50-4000 ng ml-1 for spectrofluorometry and 5.0-300 ng ml-1 for HPLC methods. The intra- and inter-day relative standard deviation (RSD) was less than 4.14 and 3.86% for spectrofluorometry and HPLC, respectively. Limit of quantitation was determined as 30 and 5.0 ng ml-1 for spectrofluorometry and HPLC, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial metoprolol dosage forms to quantify the drug and to check the formulation content uniformity.

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ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NORFLOXACIN PRESENT IN TASTE MASKED DRUG RESIN COMPLEX

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i4.24155 ◽

2018 ◽

Vol 11 (4) ◽

pp. 244

Author(s):

Ayya Rajendra Prasad ◽

Jayanthi Vijaya Ratna

Keyword(s):

Spectrophotometric Method ◽

Absorption Maximum ◽

Method Development ◽

Limit Of Detection ◽

Statistical Parameters ◽

Limit Of Quantification ◽

Relative Standard ◽

Validation Parameters ◽

Development And Validation

Objective: The objective of this study was developed and validated a novel, specific, precise, and simple ultraviolet (UV)-spectrophotometric method for the estimation of norfloxacin present in taste masked drug-resin complex.Methods: UV-spectrophotometric determination was performed with ELICO SL 1500 UV-visible spectrophotometer using 0.1 N HCl as a medium. The spectrum of the standard solution was run from 200 to 400 nm range for the determination of absorption maximum (λ max). λ max of norfloxacin was found at 278 nm. The absorbance of standard solutions of 1, 2, 3, 4, and 5 μg/ml of drug solution was measured at an absorption maximum at 278 nm against the blank. Then, a graph was plotted by taking concentration on X-axis and absorbance on Y-axis which gave a straight line. Validation parameters such as linearity and range, selectivity and specificity, limit of detection (LOD) and limit of quantification (LOQ), accuracy, precision, and robustness were evaluated as per the International Conference on Harmonization (ICH) guidelines.Results: Linearity for the UV-spectrophotometric method was noted over a concentration range of 1–5 μg/ml with a correlation coefficient of 0.9995. The LOD and LOQ for norfloxacin were found at 0.39 μg/ml and 1.19 μg/ml, respectively. Accuracy was in between 99.00% and 99.17%. % relative standard deviation for repeatability, intraday precision, and interday precision was found to be 0.600, in between 0.291 and 0.410, and in between 0.682 and 1.439, respectively. The proposed UV spectrophotometric method is found to be robust.Conclusion: The proposed UV-spectrophotometric method was validated according to the ICH guidelines, and results and statistical parameters demonstrated that the developed method is sensitive, precise, reliable, and simple for the estimation of norfloxacin present in taste masked drug-resin complex.

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Direct Spectrophotometric Determination of Perindopril Erbumine and Enalapril Maleate in Pure and Pharmaceutical Dosage Forms using Bromocresol Green

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00570 ◽

2021 ◽

pp. 3276-3282

Author(s):

Amir Alhaj Sakur ◽

Bayan Balid

Keyword(s):

Limit Of Detection ◽

Pharmaceutical Formulations ◽

Pharmaceutical Products ◽

Dosage Forms ◽

Bromocresol Green ◽

Pharmaceutical Dosage Forms ◽

Enalapril Maleate ◽

Spectrophotometric Methods ◽

Perindopril Erbumine

In this article, it has been reported new, simple, sensitive and direct spectrophotometric methods for the determination of Perindopril Erbumine (PPE) and Enalapril Maleate (ENL) in pure and in pharmaceutical forms. Spectrophotometric methods are based on the formation of yellow colored ion-pair complexes between PPE, ENL and sulphonphthalein acid dye, Bromocresol green (BCG) into chloroform were measured at the wavelength of 414 and 415nm for PPE and ENL, respectively. The optimal analytical conditions were determined. The obtained complexes (BCG: PPE) and (BCG: ENL) reached maximum absorbance directly after formation at room temperature for a stability period of 24 h. Beer’s law were obeyed in the concentration ranges of (2-20)µg/mL for PPE and (8- 44)µg/mL for ENL, the limit of detection of 0.125μg/mL and 0.230μg/mL were found for PPE and ENL, respectively. The molar absorptivity coefficients were 4.4045*104 L.moL-1.cm-1 for PPE and 1,9330*104 L.moL-1.cm-1 for ENL. The stoichiometry of the complexes formed between PPE, ENL and BCG were 1:1. No interference was observed from common excipients occurred in pharmaceutical formulations and the proposed methods have been successfully applied to determine the PPE and ENL in some pharmaceutical products and in ENL combination dosage forms with hydrochlorothiazide (HCTZ). The proposed methods were successfully validated to be utilized in the quantitative analysis of PPE and ENL in their pure and pharmaceutical products. A good agreement between the developed spectrophotometric methods with the results obtained from official reference methods for the determination of the two drugs in some real samples demonstrate that the proposed methods were suitable to quantify PPE and ENL in pharmaceutical formulations.

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