Quality Management in Drug Analysis

Mehta, A. C.

doi:10.1039/a700563f

Cited by 17 publications

(7 citation statements)

References 33 publications

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“…Method validation addressing selectivity, linearity (concentration-detector response relationship), sensitivity, detection and quantitation limits, accuracy, recovery from the matrix and precision was performed according to the publications of Metha [10], Green [11], and Rodríguez et al [12].…”

Section: Methods Validationmentioning

confidence: 99%

Simltaneous determination of organic acids and sweeteners in soft drinks by ion-exclusion HPLC

et al. 2001

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Section: Methods Validationmentioning

confidence: 99%

Simltaneous determination of organic acids and sweeteners in soft drinks by ion-exclusion HPLC

et al. 2001

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“…According Mehta (1997) requirements the selectivity of the proposed method is right because the peaks showed resolutions ≥1.5 for all the determined compounds. To confirm the accuracy of the method, ten replicate analysis of a standard solution were performed.…”

Section: Accuracymentioning

confidence: 99%

Determination of Ions (Anion and Cation) by Ion Chromatography in Drinking Water From Talkha Territory and Some Its Villages, Dakahlia, Egypt

Dawood

Sanad

2014

Journal of Agricultural Chemistry and Biotechnology

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A simple, fast and sensitive ion chromatography (IC) method, for the determination of common inos (anion and cation) in water samples was developed. For comparison, selected samples of tap water, underground water, bottled mineral water and filtered tap water were collected and determined from Talkha and some villages, Dakahlia, Egypt. Ten ions of each anion and cation (fluoride, chloride, bromide, nitrate, sulphate, sodium, ammonium, magnesium, potassium, and calcium) were separated and analyzed, respectively. An isocratic elution with 4.5mmol/L Na2CO3, 1.0 mmol/L NaHCO3 and 42 mmol/L methanesulfonic acid (MSA), IonPac AS22 and CS16 as the separation column and DS6 heated conductivity detector was used. The validation of the analytical method was studied in terms of linearity, sensitivity and accuracy. The linearity was between 0.9922 and 0.9992. And the detection limits ranged from 0.4µg/L to 72µg/L (S/N = 3) and satisfactory repeatability (RSD < 2.82%, n = 6).The recoveries were between 91.3% and 116.6%. All water samples were within the safety and acceptable levels of the World Health Organization (WHO, 2006) guidelines. Out of the samples of drinking water, only underground water had the slightly higher levels.

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“…Various parameters as system suitability, selectivity, specificity, linearity (concentration-detector response relationship), accuracy, precision, sensitivity, detection and quantification limit recovery from the matrix were studied. 16 The system suitability was assessed by five replicate analyses of the drug at a concentration of 250 ng•mL -1 . System suitability of the method was evaluated by analyzing the repeatability, peaks symmetry (symmetry factor), theoretical plates of the column, resolution between the peaks of statins and lisinopril, mass distribution ratio (capacity factor) and relative retention.…”

Section: Validation Proceduresmentioning

confidence: 99%

Validated Method for the Simultaneous Determination of Lisinopril, Pravastatin, Atorvastatin and Rosuvastatin in API, Formulations and Human Serum by RP-HPLC

Sultana¹,

Arayne²,

Sattar

2011

Chin. J. Chem.

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Lisinopril is found to be useful in hypertension and statins as cholesterol lowering drug. Present work was designed for the simultaneous determination of lisinopril in presence of pravastatin, atorvastatin, and rosuvastatin using RP-HPLC method. A Purospher star C18 (5 µm, 25×0.46 cm) column was used with mobile phase consisting of acetonitrile∶water (60∶40 V/V, pH 3.0) with flow rate of 1.0 mL•min -1 and the quantitative evaluation was performed at 225 nm. The retention time of lisinopril was 2.0 min and for pravastatin, rosuvastatin and atorvastatin was found to be 3.1, 4.5 and 8.3 min respectively. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines. Application of the suggested procedures were successfully applied to the determination of these compounds in active pharmaceutical ingredient and in pharmaceutical preparations, with high percentage of recovery, good accuracy and precision.

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Quality Management in Drug Analysis

Cited by 17 publications

References 33 publications

Simltaneous determination of organic acids and sweeteners in soft drinks by ion-exclusion HPLC

Simltaneous determination of organic acids and sweeteners in soft drinks by ion-exclusion HPLC

Determination of Ions (Anion and Cation) by Ion Chromatography in Drinking Water From Talkha Territory and Some Its Villages, Dakahlia, Egypt

Validated Method for the Simultaneous Determination of Lisinopril, Pravastatin, Atorvastatin and Rosuvastatin in API, Formulations and Human Serum by RP-HPLC

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