scholarly journals Method Development and Validation for Multicomponent Analysis of Emtricitabine and Ritonavir in Bulk Drug by RP-HPLC

2020 ◽  
Vol 10 (6) ◽  
pp. 137-144
Author(s):  
Aman Kapoor ◽  
Amar Deep Ankalgi ◽  
Upasana Thakur ◽  
Vinay Pandit ◽  
Mahendra Singh Ashawat
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Phase Combination ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, sensitive, economic and specific reverse phase liquid chromatographic method was developed for the simultaneous estimation of Emtricitabine and Ritonavir in bulk drug. Chromatographic conditions consisted of   C-18 Column (Shim-pack) 250 x 4.6 mm, particle size 5 µm , mobile phase combination of methanol and water (80:20), flow rate 1ml per minutes, run time 15 minutes and UV detection at 251nm. . The retention time for Emtricitabine and Ritonavir were found to be   3.25 and 7.8 min and average percentage recoveries 99.42% and 99.63% respectively. The validation parameters were found to comply with ICH guidelines. These methods can be further employed in future for the routine determination of Emtricitabine and Ritonavir in bulk drug and formulation. Keyword: Emtricitabine, Ritonavir, RP-HPLC, accuracy and linearity.

scholarly journals Method Development and Validation for Multicomponent Analysis of Rosuvastatin Calcium and Losartan Potassium in Bulk Drug by RP-HPLC

2020 ◽  
Vol 10 (5-s) ◽  
pp. 76-84
Author(s):  
Pramod Kumar ◽  
Amar Deep Ankalgi ◽  
Pooja Kaushal ◽  
Mahendra Singh Ashawat
Keyword(s):  
Method Development ◽  
Losartan Potassium ◽  
Simultaneous Estimation ◽  
Average Percentage ◽  
Rp Hplc ◽  
Water Ph ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Rosuvastatin Calcium

A simple, sensitive and specific liquid chromatographic method was developed for the simultaneous estimation of Rosuvastatin calcium and Losartan potassium in bulk form. Chromatographic conditions included the  Column C-18 (Shim-pack) 250 x 4.6 mm, particle size 5 µm , mobile phase acetonitrile,  methanol and water pH 3 (orthophosphoric acid) in the ratio 20:25:55 recorded  at 233 nm. The retention time were found to be   3.55 and 4.64 min and average percentage recovery 99.42% and 99.63% for Rosuvastatin calcium and Losartan potassium respectively. The proposed method was found to comply with ICH guidelines. Keyword: Rosuvastatin calcium, Losartan potassium, RP-HPLC, accuracy and linearity.

Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC

2021 ◽  
pp. 73-78
Author(s):  
Anupam Sharma ◽  
Amar Deep Ankalgi ◽  
Arti Devi ◽  
Vinay Pandit ◽  
Mahendra Singh Ashawat
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Chromatographic Procedure ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation

A rapid isocratic chromatographic procedure for the analysis of methotrexate, hydroxychloroquine sulfate in bulk drug and pharmaceutical formulations was developed validated in the present study. The mobile phase consists of a mixture of Water: Acetonitrile: Tetrahydrofuran in the proportion of 50:40:10 and pH maintained to 3with perchloric acid. Retention time was found to be 3.0 and 3.7minutes for methotrexate and hydroxychloroquine sulfate respectively. The method was performing by using the C18 column, ODS Hypersil column with UV detection at 318nm, and flow rate of 1.0ml/min. The percentage of recovery for both drugs was found to be 99.99%. All validation parameters were within limits as per the ICH guidelines.

scholarly journals Method development and validation for simultaneous estimation of methotrexate and curcumin in Bulk Drug by using RP-HPLC

2019 ◽  
Vol 9 (6-s) ◽  
pp. 127-135
Author(s):  
Amar Deep Ankalgi ◽  
Nitin Kumar Chaudhary ◽  
Pooja Kaushal ◽  
Mahendra Singh Ashawat
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Economic Method ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Natural Herb ◽  
Development And Validation

Curcumin is the natural herb that shows effect in the treatment of cancer and rheumatoid arthritis and methotrexate is well known anticancer and anti-rheumatoid drug. Literature survey reveals that there was no method available for the selected drug combination. So, here an attempt has been made to develop simple, rapid and economic method for simultaneous estimation of methotrexate and curcumin in bulk drug by using RP-HPLC method. The percentage assay from optimized method was found to be 99.68% and 99.76% for methotrexate and curcumin respectively.  The proposed method was validated for  linearity, accuracy, precision and robustness according to ICH guidelines and were found to be   within the standard range. Keywords: RP- HPLC, methotrexate, Linearity, anticancer

scholarly journals DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CURCUMIN AND PIPERINE

2018 ◽  
Vol 10 (5) ◽  
pp. 43
Author(s):  
Ankita Khismatrao ◽  
Srinivas Bhairy ◽  
Rajashree Hirlekar
Keyword(s):  
High Performance ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Phase Combination ◽  
Development And Validation ◽  
Liquid Chromatographic

Objective: The present study was aimed to develop a simple, sensitive and precise high performance liquid chromatographic (HPLC) method for the simultaneous estimation of curcumin and piperine and to implement the developed method for the estimation of curcumin and piperine in the nanoparticulate formulation.Methods: Method development was performed using various solvent, buffer-solvent ratios, at different flow rates for adequate separation of both drugs. The developed method was validated in accordance with the international conference on harmonization (ICH) guidelines. The developed method was implemented to estimate the amount of curcumin and piperine in the nanoparticulate formulation.Results: Chromatographical conditions were optimized, and the best chromatographical conditions with adequate resolution for curcumin and piperine was achieved using enable C18G reverse phase column, using a mobile phase combination of acetonitrile and phosphate buffer (pH 3)in a ratio of 70:30 v/v at a flow rate of 1.0 ml/min. The detection was monitored at a wavelength of 360 nm. The retention time of curcumin and piperine was found to be 7.2 min and 8.5 min respectively.Conclusion: The developed analytical method is simple, precise, and reproducible and thus can be used for simultaneous estimation of curcumin and piperine in pharmaceutical formulations.

scholarly journals STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC

2020 ◽  
pp. 307-318
Author(s):  
RowthulaPrasanna Surya Bhavani RowthulaPrasanna Surya Bhavani ◽  
M.Sandhya Maduri M.Sandhya Maduri
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage

A new, simple, precise, accurate, and reproducible RP-HPLC for stability-indicating method development and validation of Ledipasvir and Sofosbuvir in bulk form. Separation ofLedipasvir and Sofosbuvir was successfully achieved Dona Zorbax C8, 250 X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: Methanol (45:55) at a flow rate of 1.0mL/min and the eluate was monitored at 238nm, with a retention time of 3.303 and 7.303minutes for Ledipasvir and Sofosbuvir respectively. The method was validated and their response was found to be linear in the drug concentration range of 45µg/ml to135 µg/ml for Ledipasvirand 200µg/ml to 600 µg/ml for and Sofosbuvir. The values of the correlation coefficient were found to 0.999 for Ledipasvirand 1 for Sofosbuvir respectively. The LOQ for Ledipasvirwere found to be  0.695 respectively. The LOQ for Sofosbuvir was found to be 2.2063 respectively. This method was found to be a good percentage recovery for Ledipasvir and Sofosbuvirwere found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows a good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from the excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity, and Robustness.

Development and Validation of the Analytical method for the estimation of a combination of 5-fluorouracil and Imiquimod by RP-HPLC

2021 ◽  
pp. 3313-3318
Author(s):  
Bhupender Tomar ◽  
Ankita Sharma ◽  
Inder Kumar ◽  
Sandeep Jain ◽  
Pallavi Ahirrao
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Pharmaceutical Ingredients ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, precise, and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) was developed and validated for the estimation of the combination of 5- Fluorouracil (5-FU) and Imiquimod in active pharmaceutical ingredients (APIs). The method was carried out on Phenomenex C18 (250 × 4.6mm I.D., 5𝜇m) using isocratic elution mode. The mobile phase was used as Acetonitrile: 10mM potassium dihydrogen orthophosphate: triethylamine (40:59.9:0.1, v/v, pH 4.5 with orthophosphoric acid) and Water: ACN (50:50 v/v) was used as a diluent. The concentration of solvents was 1-20µg/ml and the volume of injection was 20µl with the flow rate of 1.2ml/min. The retention times for 5-FU and Imiquimod were found to be 1.9±0.5 and 6.6±0.5 min respectively. The absorption maxima of 5FU and Imiquimod were found 267nm and 227nm respectively. The method was validated as per ICH guidelines. All the data were found within the specified limits. The limit of detection (LOD) and limit of quantification (LOQ) of 5- Fluorouracil were found to be 0.015μg/mL and 0.048 μg/mL, respectively, and Imiquimod was found to be 0.078μg/mL and 0.237μg/mL, respectively. The method developed in the present study was found to be sensitive, specific, and precise and can be applied for the simultaneous estimation of 5-FU and Imiquimod.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Clarithromycin and Paracetamol

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Sadana Gangishetty ◽  
Surajpal Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Development And Validation

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of clarithromycin (CLA) and paracetamol (PCM). C18 column (Kromasil ODS, 5 µm, 250 × 4.6 mm) and a mobile phase containing phosphate buffer (0.05 M) along with 1-octane sulphonic acid sodium salt monohydrate (0.005 M) adjusted to pH 3.2: acetonitrile (50 : 50 v/v) mixture was used for the separation and quantification. The flow rate was 1.0 mL/min and the eluents were detected by UV detector at 205 nm. The retention times were found to be 2.21 and 3.73 mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175 µg/mL for both drugs. The developed method was applied successfully for assay of clarithromycin and paracetamol in their combined in-house developed dosage forms and in vitro dissolution studies.

scholarly journals Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC

2015 ◽  
Vol 51 (3) ◽  
pp. 653-661 ◽  
Author(s):  
Priyanka S. Jadhav ◽  
Priti M. Jamkar ◽  
Amelia M. Avachat
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Atorvastatin Calcium ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic

The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using Cosmosil-C18 column (4.6 mm´250 mm, 5 m) at 25 °C using acetonitrile: ammonium acetate buffer pH 5.0: methanol (50:25:25 v/v/v) as mobile phase. The detection was carried out at 277nm with a flow rate of 1.0mL/min. The retention times of Atorvastatin calcium and Celecoxib were 6.195 and 3.989min, respectively. The method was validated according to ICH guidelines, for specificity, precision, linearity, accuracy and robustness. Atorvastatin calcium and Celecoxib were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation was observed in oxidation and acid hydrolysis. The linearity for atorvastatin calcium and celecoxib were in the range of 100-500 µg/mL. The recovery study of atorvastatin and celecoxib were found to be in the range of 98.96 - 99.92% and 98.90-100%, respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Celecoxib in combined in-house niosomal formulation.

scholarly journals Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

2020 ◽  
Vol 10 (4) ◽  
pp. 97-101
Author(s):  
Mithun Rudrapal ◽  
Nazim Hussain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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