Simple Hplc Method Development for the Estimation of Galantamine Hydrobromide in Extended-Release Formulation

For the determination of Galantamine Hydrobromide in bulk and produced extended formulation, a new sensitive and quick HPLC technique was developed and validated according to ICH guidelines. The HPLC analysis was carried out using a waters system with a Thermo Scientific C18 (steel column (5 µm, 250mm × 4.6 mm)) column and a mobile phase of 0.1M phosphate buffer: Acetonitrile (40:60V/V) pH adjusted to 4.5 with orthophosphoric acid, at a flow rate of 1.0 mL/min. The detection was done at a wavelength of 203 nm, and galantamine hydrobromide had a retention time of 8.0 minutes. Over the concentration range of 1-10 g/ml, the calibration plot revealed a linear relationship. The accuracy of the proposed method was determined by recovery studies and was found to be near to 100 and % RSD value was found less than 2. The repeatability testing for both standard and sample solutions showed that the method is precise within the acceptable limits. RSD % of the determination of precision was <2%. The proposed method showed excellent linearity, accuracy, precision, specificity, robustness and system suitability results within the acceptance criteria. In addition, Saturation solubility of Galantamine Hydrobromide was determined in different pH mediums and it was found that Galantamine Hydrobromide has pH-dependent solubility, freely soluble in alkaline pH, and insoluble in acidic pH.

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HPLC METHOD DEVELOPMENT FOR ESTIMATION OF RAMELTEON IN TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.50.06.p0020 ◽

2013 ◽

Vol 50 (06) ◽

pp. 20-23

Author(s):

S Sahoo ◽

◽

P. K. Panda ◽

S. K. Mishra

Keyword(s):

Flow Rate ◽

Dosage Form ◽

Method Development ◽

Hplc Method ◽

Reverse Phase Hplc ◽

Ich Guidelines ◽

Hplc Method Development ◽

Tablet Dosage ◽

Good Agreement

A simple, fast, accurate and precise reverse phase HPLC method is developed and described for the determination of ramelteon in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 7.0 (35:65 V/V) as the mobile phase at a flow rate of 1.0 mL/min with detection at 286 nm. The retention time of the drug was 7.7 min. The procedure was validated for linearity, precision, accuracy, and robustness. The developed method was validated for linearity from 50 to 150% which shows the method is quite linear with a correlation coefficient of 0.999, for precision which includes system precision, method precision, intraday and by another analyst on another day, and accuracy. The %RSD for system precision was observed to be 1.1, whereas the method precision was observed to be 0.2. The % recovery from ‘accuracy’ studies yielded the recovery of 99.7-101.5% which indicates the capability of the method, and finally for robustness that includes studies w.r.t. change in flow rate, the percentage of organic modifier and pH. As per ICH guidelines, method validation results are in good agreement. The proposed method was simple, sensitive, precise and accurate.

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RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF AMPHOTERICIN B

INDIAN DRUGS ◽

10.53879/id.51.02.p0016 ◽

2014 ◽

Vol 51 (02) ◽

pp. 16-20

Author(s):

L Mohankrishna ◽

◽

P. J. Reddy ◽

B. P Reddy. ◽

P. Navya

Keyword(s):

Amphotericin B ◽

Mobile Phase ◽

Method Development ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Ich Guidelines ◽

Relative Standard ◽

Phase Combination ◽

Hplc Method Development

A sensitive and precise HPLC procedure has been developed for the assay of amphotericin B in bulk samples and pharmaceutical formulations by using a C18 column [Kromosil, C18, (5 µm, 4.6mm x 250 mm; Make. Waters)], and mobile phase combination is 1% formic acid in water and acetonitrile in ratio of 45:55 V/V. The procedure has been validated as per the ICH guidelines. The λmax of detection was fixed at 407 nm, so that there was less interference from mobile phase with highest sensitivity according to UV analysis. Calibration plots were linear in the range of 10-100 µg/mL and the LOD and LOQ were 0.02 µg/mL and 0.06 µg/mL respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of amphotericin B in different formulations.

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Stability Indicating RP-HPLC Method Development and Validation for the Determination of Solifenacin Succinate in Bulk and its Pharmaceutical Formulation

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00608 ◽

2021 ◽

pp. 3509-3514

Author(s):

A. Tanuja ◽

S. Ganapaty ◽

Varanasi S N Murthy

Keyword(s):

Method Development ◽

Current Method ◽

Hplc Method ◽

Pharmaceutical Ingredients ◽

Solifenacin Succinate ◽

Ich Guidelines ◽

Degradation Studies ◽

Hplc Method Development ◽

Development And Validation

The current work aims to establish a novel and advanced reverse phase isocratic liquid chromatography system followed by validation and to conduct stability analysis in active pharmaceutical ingredients and formulations for the quantification of Solifenacin Succinate. The optimized elution was achieved with column Sunfire C8 (4.6 x 150mm, 5µm), using the mobile phase of Buffer: Methanol: Acetonitrile in the composition ratio of 45:45:10 v/v. The wavelength of detection was selected as 220nm with 1.0ml/ min flow rate and 30μl injection volume. The retention time of Solifenacin Succinate was found 2.94 min respectively. The method developed has been validated for various analytical parameters according to ICH guidelines. The Linearity was attained at 20 to100 μg/ml of concentration range. The established method was proved as reproducible. The Assay was obtained as 100.40%. The degradation studies were carried out at all degradative conditions and the results of degradation studies denote that the current method was specific, reliable, and economical. Hence, the developed method can be applied for the qualitative and quantitative determination of the selected drug and its commercial formulations.

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Stability indicating RP-HPLC method development for docetaxel trihydrate

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v9i4-s.3362 ◽

2019 ◽

Vol 9 (4-s) ◽

pp. 525-528 ◽

Cited By ~ 1

Author(s):

Nilesh R. Rarokar ◽

Pramod B. Khedekar

Keyword(s):

Room Temperature ◽

Method Development ◽

Hplc Method ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

System Suitability ◽

Steel Column ◽

Stainless Steel Column ◽

Bulk Drug ◽

Hplc Method Development

The purpose of present study was to develop RP-HPLC method for estimation of docetaxel trihydrate which should be a suitable, simple, precise, accurate, robust, and reproducible. The samples were assayed by the Shimadzu HPLC instrument - LC-20AD (Japan) equipped with Shimadzu SPD-M20A UV-VIS detector operated at wavelength of 230 nm. The binary gradiant pump was used for the analytical method development. The reverse phase stainless steel column (150 × 4.6 mm) packed with 5 μm particles (C-8, LiCrosphore® 100, Germany) was used to take chromatograph. A mobile phase consisting of acetonitrile/phosphate buffer 20 mM, (45:55, v/v), pH 3.5 adjusted with o-phosphoric acid at a flow rate of 1 mL/min. The method was validated by system suitability and reproducibility. The linearity was also determined using samples with five different concentrations of 20, 40, 60, 80 and 100 µg/mL. The results of the study showed that the developed RP-HPLC method is simple and robust which is useful for the estimation of docetaxel trihydrate in bulk drug and in pharmaceutical dosage form. The results of stability show that the method has stability over a period of 48 h at room temperature. Keyword: Docetxel trihydrate, RP-HPLC method, validation, stability

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Determination of Chromones in Dysophylla stellata by HPLC: Method Development, Validation and Comparison of Different Extraction Methods

Natural Product Communications ◽

10.1177/1934578x1000500412 ◽

2010 ◽

Vol 5 (4) ◽

pp. 1934578X1000500 ◽

Cited By ~ 1

Author(s):

Raju Gautam ◽

Amit Srivastava ◽

Sanjay M. Jachak

Keyword(s):

Method Development ◽

Gradient Elution ◽

Extraction Methods ◽

Hplc Method ◽

Ich Guidelines ◽

Method Development And Validation ◽

Efficient Extraction ◽

Hplc Method Development ◽

Development And Validation

An HPLC method with reflux as an efficient extraction method has been developed for quantification of chromones in Dysophylla stellata Benth. Separation was achieved on a C18 column with a mobile phase of 0.5% (v/v) acetic acid in water (A), and ACN (B) under gradient elution at 1 mL/min. Chromones (1 and 2) isolated from D. stellata were used as standards for method development and validation was achieved according to ICH guidelines. Extracts prepared by three different methods [reflux, ultrasonication and accelerated solvent extraction (ASE)] were used for analysis by the validated method. The proposed HPLC method is simple, accurate and selective for the separation and quantification of chromones in D. stellata.

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Stability indicating RP-HPLC method development and validation for the simultaneous estimation of ceftriaxone and tazobactum in sterile powder for injection

International Journal of Research In Pharmaceutical Chemistry and Analysis ◽

10.33974/ijrpca.v1i2.62 ◽

2019 ◽

Vol 1 (2) ◽

pp. 40-43

Author(s):

T. Vimalakkannan ◽

P. Shaik Parveen ◽

Salomi ◽

K. Ravindra Reddy

Keyword(s):

Method Development ◽

Pharmaceutical Formulations ◽

Accurate Method ◽

Hplc Method ◽

Simultaneous Estimation ◽

Ich Guidelines ◽

Method Development And Validation ◽

Hplc Method Development ◽

Development And Validation

A simple, rapid, precise and accurate method is developed for the quantitative simultaneous determination of ceftriaxone and tazobactum in bulk and pharmaceutical formulations. Separation of ceftriaxone and tazobactum was successfully achieved by using Inertsil C18 ODS column 250X4.6mm, 5µm in an isocratic mode using water and acetonitrile (80:20) at a flow rate of 1.0 ml/min and was monitored at 254 nm with a retention time of 3.049 minutes and 4.317 minutes for ceftriaxone and tazobactum respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/ml to 80 µg/ml for ceftriaxone and 5 µg/ml to 35 µg/ml for tazobactum. The values of the correlation coefficient were found to be 0.999 for ceftriaxone and 0.999 for tazobactum respectively. The LOD and LOQ for ceftriaxone were found to be 0.021 and 0.064 respectively. The LOD and LOQ for tazobactum were found to be 0.030 and 0.091 respectively. The percentage recovery for ceftriaxone and tazobactum were found to be 98-102% respectively which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness. Stability of the drugs was determined by using acid/base, thermal, oxidative stress testing.

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