scholarly journals STABILITY-INDICATING REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF DARUNAVIR AND RITONAVIR

2016 ◽  
pp. 66
Author(s):  
Sindu Priya Dasyam ◽  
Gowri Sankar D ◽  
Masthanamma Sk
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating

<p>ABSTRACT<br />Objective: The main objective of the proposed study was to develop and validate a new stability indicating reverse phase high performance liquid<br />chromatography method for the simultaneous estimation of darunavir (DRV) and ritonavir (RTV).<br />Methods: The method was optimized using Atlantis C18 column (50 mm×4.6 mm, 5 µm, Waters Corporation, Milford, USA). Acetonitrile and water<br />were used as mobile phase in the proportion of 60:40. The flow rate was 0.8 ml/minutes and the effluent was monitored at 230 nm.<br />Results: The retention time of DRV and RTV was 3.15 minutes and 4.59 minutes, respectively. The method was precise as it showed a % relative<br />standard deviation of &lt;2%. The percentage recoveries of both the drugs DRV and RTV were 99.8-100.01% and 99.5-99.97%, respectively. The<br />linearity of DRV and RTV was in the range of 40-120 and 4-20 µg/ml, respectively. Calibration curve showed good linearity and range. The correlation<br />coefficient of DRV and RTV was 0.999 each. Moreover, the results obtained for limit of quantification, limit of detection, robustness, and ruggedness<br />were well within the acceptance criteria.<br />Conclusion: The proposed method was found to be simple, rapid, accurate, precise, and stability indicating. It was found to be economical and suitable<br />for simultaneous determination of DRV and RTV which is can also be applied for pharmaceutical dosage form.<br />Keywords: Darunavir, Ritonavir, Reversed-phase-high performance liquid chromatography, Simultaneous estimation, Forced degradation.</p>

scholarly journals Development and Validation of Stability-Indicating Assay Method by RP-HPLC for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Form

2020 ◽  
Vol 10 (4) ◽  
pp. 79-86
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Rosuvastatin Calcium

A Simple, precise, and accurate stability-indicating reversed-phase high-performance liquid chromatography method has been established for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined bulk and tablet formulation. The chromatographic separation was performed on reverse phase Princeton (C18) (250 mm x 4.6 mm, 5µ) column with mobile phase as a mixture of water (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio (40:60) v/v at the flow rate 1.0 ml/min. Detection was carried out at wavelength 240 nm. The retention time under the optimized condition of Rosuvastatin calcium and Fenofibrate was found to be 2.485 & 3.905 minutes respectively. The calibration curve was linear in the range of 6-16 µg/ml and 87-232 µg/ml for rosuvastatin calcium and fenofibrate with a correlation coefficient of 0.9999 and 0.9994 respectively. Relative standard deviation values for all key parameters were less than 2.0%. The percentage recovery was found to be 99.66-100.37% and 99.13-100.44% for rosuvastatin calcium and fenofibrate respectively. The developed reversed-phase high-performance liquid chromatography method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of rosuvastatin calcium and fenofibrate in bulk and tablet formulations.  Keywords: Rosuvastatin calcium, Fenofibrate, RP-HPLC, Method validation, ICH guidelines.

scholarly journals Development and Validation of Stability-Indicating Reverse Phase-High Performance Liquid Chromatography Method for Simultaneous Determination of Atenolol and Nifedipine in Bulk and Tablet Dosage Form

2020 ◽  
Vol 11 (02) ◽  
pp. 219-223
Author(s):  
Ansari Yaasir Ahmed ◽  
Qazi Shoeb ◽  
Umme Rumana ◽  
Patel Afroza ◽  
Pathan Vahid Tajkhan ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Limit Of Quantitation

The new stability-indicating high performance liquid chromatography (HPLC) method has been developed and validated with different parameters for atenolol (ATE) and nifedipine (NIFE) in the combined dosage form. The chromatographic conditions were optimized using a mobile phase of MeOH:OPA (70:30) with a flow rate of 0.7 mL/min. Column (C18) of 4.6 × 250 mm dimension was used as a stationary phase; the particle size capacity of the column was 5 μm. The detection was carried out at 233 nm. The method was validated according to ICH guidelines for linearity, precision, repeatability, the limit of detection (LoD), and limit of quantitation (LoQ). The response was found to be linear in the concentration range of 20 to 100 mcg/mL for ATE and 1 to 5 mcg/mL for NIFE. The developed method shows the minimum quantity of drugs to be identified (LoD) and minimum drug to be quantified (LoQ). The LoD and LoQ were found to be 0.1415 and 0.4289, respectively, for ATE, and 0.1834 and 0.5558, respectively, for NIFE. The method was linear, simple, precise, and accurate and, therefore, suitable for routine analysis of drugs in tablet form. The forced degradation studies were also done through the exposure of analyte solution to four different stress conditions.

Development and Validation of A Reversed Phase-High Performance Liquid Chromatography Method for the Quantitative Estimation of Ramipril Drug Content from Formulated Dosage Form

2016 ◽  
Vol 6 (3) ◽  
Author(s):  
Raju Chandra ◽  
Manisha Pant ◽  
Harchan Singh ◽  
Deepak Kumar ◽  
Ashwani Sanghi
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Active Ingredient ◽  
High Performance ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Reversed Phase ◽  
Uv Detector ◽  
Chromatography Method ◽  
Drug Content

A reliable and reproducible reversed-phase high performance liquid chromatography (RP-HPLC) was developed for the quantitative determination of Remipril drug content from marketed bulk tablets. The active ingredient of Remipril separation achieved with C18 column using the methanol water mobile phase in the ratio of 40:60 (v/v). The active ingredient of the drug content quantify with UV detector at 215 nm. The retention time of Remipril is 5.63 min. A good linearity relation (R2=0.999) was obtained between drug concentration and average peak areas. The limit of detection and limit of quantification of the instrument were calculated 0.03 and 0.09 µg/mL, respectively. The accuracy of the method validation was determined 102.72% by recoveries method.

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Dextromethorphan Hydrobromide

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.

Determination of Mimosine and 2,3-Dihydroxypyridine in Leucaena leucocephala by Reversed Phase High-Performance Liquid Chromatography

2011 ◽  
Vol 140 ◽  
pp. 296-301 ◽  
Author(s):  
Cai Mei Wu ◽  
Hong Min Yuan ◽  
Gang Jia ◽  
Zhi Sheng Wang ◽  
Xiu Qun Wu
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Leucaena Leucocephala ◽  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Quantitative Detection ◽  
Uv Detector ◽  
Chromatography Method

A reversed high performance liquid chromatography method was developed for the quantitative determination of mimosine and 2,3-DHP in leaves ofLeucaena Leucocephala. Mimosine and 2,3DHP were extracted using 0.1N HCl.The chromatograph conditions were investigated and optimized. The optimal HPLC conditions as follows: Agilent HC-C18 column （4.6×150mm,5μm） was used at 30°C. The method used a variable wavelength UV detector at 280nm, the mobile phase consisted of 0.2 % (w/v) orthophosphoric acid and methanol, the gradient elution was adopted. The injection volume was 10μL. The linearity is favorable in the range of 1.0 to 50μg mL-1with a correlation coefficient of 0.99998 for mimosine and 0.99902 for 2,3DHP. Under the optimal conditions, the method limit of detection (LOD) of mimosine and 2,3DHP were 0.40mg/kg and 0.55mg/kg respectively. The recovery of mimosine was 87.00-94.70% with the RSD (n=5) of 2.75-3.81% in the spiked levels 0,1, 5, 20mg/g. At the same time, the recovery of 2,3DHP was 88-95.4% with the RSD (n=5) of 2.24-4.90%. The method was found to be simple, sensitive, fast and accurate, and has been applied successfully for the quantitative detection of mimosine and 2,3-DHP in leaves ofLeucaena Leucocephala, plasma and excretion of ruminant.

scholarly journals A NEW REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF SERRATIOPEPTIDASE AND DICLOFENAC SODIUM IN BULK AND TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 150
Author(s):  
Manasi Kulkarni B ◽  
Anagha Joshi M
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective is to study the development of a simple, rapid, specific, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of serratiopeptidase (SER) and diclofenac (DC) sodium in bulk and tablet formulation.Methods: RP-HPLC method was developed for the simultaneous estimation of SER and DC sodium in tablet formulation. The separation was achieved by Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with phosphate buffer pH-7 and o-phosphoric acid:methanol:acetonitrile (5:4:1% v/v/v). Flow rate was maintained at 1 mL/min and UV detection was carried at 270 nm.Result: For RP-HPLC method, the retention time for SER and DC sodium was found to be 3.3833 min and 8.1667 min, respectively. The method was validated for accuracy, precision, and specificity. Linearity for SER and DC sodium was in the range of 5–50 μg/ml.Conclusion: The developed RP-HPLC method is simple, accurate, rapid, sensitive, precise, and economic. Hence, this method can be employed successfully for the estimation of SER and DC sodium in both bulk and tablet dosage forms.

scholarly journals A NEW REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF SERRATIOPEPTIDASE AND DICLOFENAC SODIUM IN BULK AND TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 150
Author(s):  
Manasi Kulkarni B ◽  
Anagha Joshi M
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective is to study the development of a simple, rapid, specific, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of serratiopeptidase (SER) and diclofenac (DC) sodium in bulk and tablet formulation.Methods: RP-HPLC method was developed for the simultaneous estimation of SER and DC sodium in tablet formulation. The separation was achieved by Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with phosphate buffer pH-7 and o-phosphoric acid:methanol:acetonitrile (5:4:1% v/v/v). Flow rate was maintained at 1 mL/min and UV detection was carried at 270 nm.Result: For RP-HPLC method, the retention time for SER and DC sodium was found to be 3.3833 min and 8.1667 min, respectively. The method was validated for accuracy, precision, and specificity. Linearity for SER and DC sodium was in the range of 5–50 μg/ml.Conclusion: The developed RP-HPLC method is simple, accurate, rapid, sensitive, precise, and economic. Hence, this method can be employed successfully for the estimation of SER and DC sodium in both bulk and tablet dosage forms.

scholarly journals A SIMULTANEOUS ESTIMATION, VALIDATION AND FORCED DEGRADATION STUDIES OF 5-FLUOROURACIL AND TEGAFUR IN A PHARMACEUTICAL DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

2018 ◽  
Vol 11 (12) ◽  
pp. 132
Author(s):  
Vaishali Mistry ◽  
Akshay Yelwe ◽  
Amey Deshpande
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Stability Indicating ◽  
Rp Hplc ◽  
The Stability

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of 5-fluorouracil and tegafur in pharmaceutical dosage forms.Method: 5-fluorouracil and tegafur the propose RP-HPLC method were developed by using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic separation was carried on shim-pack gist c18 (250 × 4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 50:50% v/v and elements were scanned using a UV detector at 271 nm.Result: The retention time of 5-fluorouracil and tegafur was found to be 2.74 and 3.66 min, respectively. A linearity response was observed in the concentration range of 13.4 μg/ml–31.3 μg/ml for 5-fluorouracil and 6 μg/ml–14 μg/ml for tegafur, respectively. Limit of detection and limit of quantification of 5-fluorouracil were 10.97 μg/ml and 33.26 μg/ml and for tegafur are 4.89 μg/ml and 14.83 μg/ml, respectively.Conclusion: The stability indicating that the method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR BY REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND TABLET DOSAGE FORMS

2017 ◽  
Vol 10 (11) ◽  
pp. 59
Author(s):  
Sufiyan Ahmad ◽  
Mohammed Rageeb Mohammed Usman
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

  Objective: A simple rapid, accurate, precise, and reproducible validated reversed-phase high performance liquid chromatography method was developed for the determination of emtricitabine (EMB) and tenofovir (TEN) in bulk and tablet dosage forms.Methods: The quantification was carried out using symmetry Premsil C18 (250 mm×4.6 mm, 5 μm) Younglin (S.K.) gradient way using mobile phase comprising of methanol:water (70:30 v/v) pH 3 and a detection wavelength of 273 nm, and injection volume of 20 μL, with a flow rate of 1 ml/minutes.Results: In the developed method, the retention time of EMB and TEN were found to be 3.1667 minutes and 7.5000 minutes. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines.Conclusion: The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible. Hence, it is worthwhile that the proposed methods can be successfully utilized for the routine quality control analysis EMB and TEN in bulk drug as well as in formulations.

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