scholarly journals Development and Validation of an HPLC Method for Determination of Ziprasidone and Its Impurities in Pharmaceutical Dosage Forms

2011 ◽  
Vol 94 (3) ◽  
pp. 713-722 ◽  
Author(s):  
Marija Pavlovic ◽  
Marija Malesevic ◽  
Katarina Nikolic ◽  
Danica Agbaba
Keyword(s):  
Mobile Phase ◽  
Raw Materials ◽  
Dosage Forms ◽  
Hplc Method ◽  
Array Detector ◽  
Least Squares Regression ◽  
Experimental Conditions ◽  
Pharmaceutical Dosage Forms ◽  
Development And Validation

Abstract Ziprasidone is known as a novel “atypical” or “second-generation” antipsychotic drug. A sensitive and reproducible method was developed and validated for determination of ziprasidone and its major impurities, which are significantly different in polarity. The separation is performed on a Waters Spherisorb® octadecylsilyl 1 column (5.0 μm particle size, 250 × 4.6 mm id) using a gradient with mobile phase A [buffer–acetonitrile (80 + 20, v/v)] and mobile phase B [buffer–acetonitrile (10 + 90, v/v)] at a working temperature of 25°C. The buffer was 0.05 M KH2PO4 solution with an addition of 10 mL triethylamine/L solution, adjusted to pH 2.5 with orthophosphoric acid. The flow rate was 1.5 mL/min, and the eluate was monitored at 250 nm using a diode array detector. Optimization of the experimental conditions was performed using partial least squares regression, for which four factors were selected for optimization: buffer concentration, buffer pH, triethylamine concentration, and temperature. The proposed validated method is convenient and reliable for the assay and purity control in both raw materials and dosage forms.

DETERMINATION OF BIMATOPROST IN BULK AND OPHTHALMIC DOSAGE FORMS: DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (12) ◽  
pp. 49-55
Author(s):  
N. P Ambhore ◽  
◽  
P. M. Dandagi ◽  
A. P. Gadad ◽  
N. H. S. Reddy
Keyword(s):  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Suggested Approach ◽  
Rp Hplc ◽  
System Suitability ◽  
Development And Validation

The main objective of the current study was to develop a simple, accurate, precise and rapid RPHPLC method and subsequent validation using ICH suggested approach for the determination of bimatoprost in bulk and pharmaceutical dosage form. The chromatographic separation of bimatoprost was achieved on a phenomenex C18 column (150 mm × 4.6 mm; 5 μm) using PDA detector at 194 nm. The compound was separated with a mixture of acetonitrile and 0.2% triethylamine (pH 7.0 adjusted with o-phosphoric acid) in the ratio of 50:50 v/v as the optimized mobile phase at the flow rate of 1 mL/min. Chromatogram showed peak of bimatoprost at retention time of 3.8 min. The method was validated for linearity, sensitivity, precision, accuracy, system suitability and robustness. Calibrations were linear over the concentration range of 6.25-100 μg/mL as indicated by correlation coefficient (r2) of 0.999. Developed method can be applicable for routine quantitative determination of bimatoprost in pharmaceutical dosage forms.

scholarly journals Development and validation of a fast, simple, cost-effective and robust HPLC method for lisinopril determination in solid pharmaceutical dosage forms

2017 ◽  
Vol 36 (2) ◽  
pp. 201 ◽  
Author(s):  
Tanja Bakovska Stoimenova ◽  
Marjan Piponski ◽  
Gordana Trendovska Serafimovska ◽  
Marina Stefova
Keyword(s):  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Cost Effective ◽  
Dosage Forms ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Operational Conditions ◽  
Development And Validation

A fast, simple, cost-effective and robust chromatographic method was developed and validated for determination of the antihypertensive drug lisinopril dihydrate in tablets under routine operational conditions, without ion-pair reagents, high column temperatures and an acidic mobile phase. Taking into consideration all four different pKa values of lisinopril, the separation was optimized using the C18 column (end-capped, 150 mm × 4.6 mm 5 µm) and a mobile phase composed of methanol and ammonium (or potassium) dihydrogen phosphate buffer (pH 7.2) with a flow rate of 1.1 ml/min, UV detection at 214 nm and a temperature of 40 °C. These optimized conditions led to the production of a single and symmetrical peak for lisinopril. This mobile phase is suitable for different HPLC columns, which makes it appropriate for industrial quality control laboratories. The developed method was validated, showing excellent validation results and the possibility to be implemented for the determination of lisinopril in combined dosage forms with other active substances.

scholarly journals RP-HPLC Determination of Raloxifene in Pharmaceuticl Tablets

2006 ◽  
Vol 3 (1) ◽  
pp. 60-64 ◽  
Author(s):  
P. Venkata Reddy ◽  
B. Sudha Rani ◽  
G. Srinu Babu ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

A reverse phase HPLC method is developed for the determination of Raloxifene in pharmaceutical dosage forms. Chromatography was carried out on an inertsil C18 column using a mixture of acetonitrile and phosphate buffer (30:70 v/v) as the mobile phase at a flow rate of 1 mL/min. Detection was carried out at 290 nm .The retention time of the drug was 10.609 min. The method produced linear responses in the concentration range of 0.5-200 µg/mL of Raloxifene. The method was found to be applicable for determination of the drug in tablets.

Development and Validation of a Reversed-Phase HPLC Method for the Determination of Deflazacort in Pharmaceutical Dosage Forms

2007 ◽  
Vol 65 (9-10) ◽  
pp. 591-594 ◽  
Author(s):  
G. M. Corrêa ◽  
L. P. Bellé ◽  
L. Bajerski ◽  
S. H. M. Borgmann ◽  
S. G. Cardoso
Keyword(s):  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Reversed Phase Hplc ◽  
Pharmaceutical Dosage Forms ◽  
Development And Validation

scholarly journals Development and validation of a stability indicating RP-HPLC-DAD method for the determination of bromazepam

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0244951
Author(s):  
Hany W. Darwish ◽  
Nesma A. Ali ◽  
Ibrahim A. Naguib ◽  
Mohamed R. El Ghobashy ◽  
Abdullah M. Al-Hossaini ◽  
...  
Keyword(s):  
Hplc Method ◽  
Array Detector ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Photodiode Array Detector ◽  
Alkaline Conditions ◽  
Development And Validation

A reliable, selective and sensitive stability-indicating RP-HPLC assay was established for the quantitation of bromazepam (BMZ) and one of the degradant and stated potential impurities; 2-(2-amino-5-bromobenzoyl) pyridine (ABP). The assay was accomplished on a C18 column (250 mm × 4.6 mm i.d., 5 μm particle size), and utilizing methanol-water (70: 30, v/v) as the mobile phase, at a flow rate of 1.0 ml min-1. HPLC detection of elute was obtained by a photodiode array detector (DAD) which was set at 230 nm. ICH guidelines were adhered for validation of proposed method regarding specificity, sensitivity, precision, linearity, accuracy, system suitability and robustness. Calibration curves of BMZ and ABP were created in the range of 1–16 μg mL-1 with mean recovery percentage of 100.02 ± 1.245 and 99.74 ± 1.124, and detection limit of 0.20 μg mL-1 and 0.24 μg mL-1 respectively. BMZ stability was inspected under various ICH forced degradation conditions and it was found to be easily degraded in acidic and alkaline conditions. The results revealed the suitability of the described methodology for the quantitation of the impurity (ABP) in a BMZ pure sample. The determination of BMZ in pharmaceutical dosage forms was conducted with the described method and showed mean percentage recovery of 99.39 ± 1.401 and 98.72 ± 1.795 (n = 6), respectively. When comparing the described procedure to a reference HPLC method statistically, no significant differences between the two methods in regard to both accuracy and precision were found.

scholarly journals Validated RP-HPLC Method for the Determination of Ivabradine Hydrochloride in Pharmaceutical Formulation

2017 ◽  
Vol 9 (05) ◽  
Author(s):  
MD. Muzaffar -ur- Rehman1 ◽  
G. Nagamallika
Keyword(s):  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug

A simple, rapid, precise, and accurate RP-HPLC method for the estimation of Ivabradine Hydrochloride an anti-anginal agent, both as a bulk drug and in pharmaceutical formulation was developed. The chromatographic separation was achieved on a Thermosil C18 150 × 4.5 mm, 5μm column by using a mobile phase containing a mixture of methanol and phosphate buffer pH 6.5 in the ratio of 65:35 % v/v at a flow rate of 1ml/min and at an ambient temperature. The detection was monitored at a wavelength of 265nm. A clear chromatographic peak was identified with the retention time of 4.36 min and tailing factor of 1.23. The developed method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method shows a good linear relationship with correlation co-efficient of more than 0.992 in the concentration range of 30μg-150μg. The method showed mean % Recovery of 100.4% and %RSD for repeatability and intermediate precision was less than 2%. The proposed method can be used successfully for the quantitative determination of Ivabradine HCL in pharmaceutical dosage forms.

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PIOGLITAZONE IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP -HPL C

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (09) ◽  
pp. 42-46
Author(s):  
M Debnath ◽  
◽  
A. S. Kumar ◽  
V. D. S Ganta
Keyword(s):  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise RP‐HPLC method was developed and validated for the determination of pioglitazone hydrochloride in pharmaceutical dosage forms. Chromatography was carried out using Kromosil- C18 ODS column (250 x 4.6 mm; 5 μm), mixture of acetate buffer: methanol (40:60 v/v) as the mobile phase at a flow rate 1.0 mL/min. The analyte was monitored using UV detector at 254 nm. The retention time for pioglitazone HCl was 3.063 min. The proposed method was found linear in the concentration range of 20.0‐70.0 μg/ml with correlation coefficient of r2=0.9999. The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for pioglitazone HCl were in the range 99.20-101.59%. Due to its simplicity, rapidness, high precision and accuracy of the proposed method it may be used for determining pioglitazone HCl in bulk and dosage forms.

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