scholarly journals Development and Validation of a Rapid RP HPLC Method for the Determination of Cinitapride Hydrogen Tartarate in Solid Oral Dosage Forms

2011 ◽  
Vol 8 (3) ◽  
pp. 1424-1429
Author(s):  
Syeda Humaira ◽  
Akalanka Dey ◽  
S.Appala Raju ◽  
Syed Sanaullah
Keyword(s):  
Pharmaceutical Formulations ◽  
Gradient Elution ◽  
Dosage Forms ◽  
Hplc Method ◽  
Oral Dosage ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Solid Dosage ◽  
Oral Dosage Forms ◽  
Development And Validation

In the present study a simple, sensitive rapid and accurate HPLC method with UV detection for the analysis of cinitapride hydrogen tartarate was developed and validated in solid dosage forms. The method utilized gradient elution technique with C18 column (150×4.6 mm I.D, 5 μm particle size) with mobile phase consisting of 0.1% formic acid in water and acetonitrile The detection wavelength was at 268 nm, with flow rate of 0.5 mL/min and injection volume of 10 μL for separation of cinitapride in bulk drugs and pharmaceutical formulations. The gradient elution was developed for better and optimized results. The developed method was validated for precision which includes system precision and method precision, accuracy and linearity studies in the concentration range of 5-100 μg/mL with correlation coefficient of 0.9987. The accuracy (recovery) was between 97.32 and 100.82%. The proposed method is simple, fast, accurate, precise and reproducible, hence can be applied for routine quality control analysis of cinitapride in pure and pharmaceutical dosage forms.

DEVELOPMENT AND VALIDATION OF RP-HPLC-PDA METHOD FOR THE ESTIMATION OF SARPOGRELATE HYDROCHLORIDE IN BULK AND DOSAGE FORMS

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (04) ◽  
pp. 77-80
Author(s):  
M Vijaya Lakshmi ◽  
◽  
K Hima Bindu ◽  
M. Pravallika ◽  
B. N. Nalluri
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Anti Platelet Drug ◽  
Sarpogrelate Hydrochloride ◽  
The Mean ◽  
Development And Validation

A simple and precise RP-HPLC method has been developed and validated for the estimation of sarpogrelate hydrochloride, an anti-platelet drug in bulk and pharmaceutical dosage forms. Sarpogrelate is an antagonist at 5HT2A and 5HT2B receptors which blocks serotonin induced platelet aggregation and has application in the treatment of diseases including diabetes mellitus, Raynaud’s disease, angina pectoris and atherosclerosis. Chromatography was carried out on a Phenomenex C18 (250 x 4.6mm, 5μm) column with a mobile phase of 10mM ammonium acetate and acetonitrile (45:55% v/v). The flow rate was 1.2mL/min. The detection wavelength was carried out at 220nm. The retention time is 3.356 minutes for sarpogrelate hydrochloride. The linearity was found in the range of 10-50 μg/ml (R = 0.999) and % RSD is less than 2%. The mean recoveries obtained for sarpogrelate hydrochloride were in the range of 98.73-100.67%. The method is validated as per ICH guidelines and can be applied for the estimation of percentage purity in Sarpogrelate hydrochloride for quality control analysis in bulk and its dosage forms.

scholarly journals Development and Validation of RP-HPLC Method for the Estimation of Gemifloxacin Mesylate in Bulk and Pharmaceutical Dosage Forms

2010 ◽  
Vol 7 (4) ◽  
pp. 1621-1627 ◽  
Author(s):  
Yunoos Mohammad ◽  
B. Pragati Kumar ◽  
Azmath Hussain ◽  
Harish
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A simple, rapid, accurate, precise and reproducible reverse phase high performance liquid chromatographic method has been developed for the estimation of gemifloxacin mesylate in bulk and pharmaceutical formulations. The quantification was carried out using cyberlab capcell pak, ODS C18(250 × 4.6 mm i.d., 5 μm particle size) column in an isocratic mode, with mobile phase comprising Buffer (KH2PO4with pH 6.8): acetonitrile in the ratio of 80:20 (%v/v).The flow rate was at 1.2 mL/min and the detection was carried out at 265 nm. The retention time of the drug was found to be 7.47 min and the method produced linear response in the concentration range of 25-150 μg/mL (R∼0.99986). The recovery studies were also carried out and % RSD from reproducibility was found to be 0.82. The proposed method was statistically evaluated and can be applied for routine quality control analysis of gemifloxacin mesylate in tablets.

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.

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

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)

scholarly journals Method Development and Validation of Pitavastatin Calcium and its Degradation Behavior under varied Stress Conditions by UV Spectrophotometric methods

2019 ◽  
Vol 18 (2) ◽  
pp. 159-169
Author(s):  
S Niranjani ◽  
K Venkatachalam
Keyword(s):  
Method Development ◽  
Correlation Coefficients ◽  
Pharmaceutical Formulations ◽  
Stability Study ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Pitavastatin Calcium ◽  
Development And Validation

UV spectrophotometric methods for the determination of pitavastatin calcium in pure and pharmaceutical dosage forms were developed and validated as per ICH guidelines. The standard pitavastatin calcium solutions were scanned between the ranges of 200-400 nm. The maximum absorbance of pitavastatin calcium in DMF (method A), HCl (method B) and NaOH (method C) was recorded at 266 nm. They obeyed Beers law concentration in the range of 10-45 μg/ml (method A), 0.25-2.0 μg/ml (method B) and 0.25-2.0 μg/ml (method C) with correlation coefficients 0.9996, 0.9998 and 0.9998 respectively. Stability study showed high stability of pitavastatin calcium in acidic, alkaline medium and at high temperature, but undergone degradation in oxidative stress condition. The developed methods were validated for linearity, precision, accuracy, LOD, LOQ, ruggedness, robustness and recovery studies. The proposed methods can be successfully used for the routine quality control analysis of pitavastatin calcium in bulk and commercial pharmaceutical formulations. Dhaka Univ. J. Pharm. Sci. 18(2): 159-169, 2019 (December)

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