scholarly journals Validated RP-HPLC Method for Simultaneous Estimation of Domperidone and Naproxen in Bulk Drug and Formulations

2020 ◽  
pp. 701-706
Keyword(s):  
Flow Rate ◽  
Drug Concentration ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Isocratic Mode ◽  
Good Percentage

A new , precise , accurate and reproducible RP – HPLC method for simultaneous estimation of bulk and pharmaceutical formulations . Separation of Naproxen and Domperidone was successfully achieved. THERMO HYPERSIL , C 18 , 250mm X 4.6mm , 5μm , or equivalent in an isocratic mode utilizing Acetonitrile : Methanol : Water (20: 60:20 ) at a flow rate of 1.0 mL/ min and elute was monitored at 284nm , with a retention time of 2.341 and 5.225 minutes for Naproxen and Domperidone respectively. The method was validated and the response was found to be linear in the drug concentration range of 1μg /mL to 6μg/mL. The values of correlation coefficient was found to be 0.988 for Naproxen and 0.998 for Domperidone respectively. The LOD and LOQ for Naproxen was found to be 0.56, 1.71 respectively . The LOD and LOQ for Domperidone was found to be 1.49 , 4.5 respectively. This method was found to be good percentage recovery for Naproxen and Domperidone were found to be 98% and 101.6% respectively indicates that the proposed method was highly accurate. The specificity of 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 .

scholarly journals Method development and method validation of guaifenesin and dextromethorphan by RP-HPLC

2018 ◽  
Vol 1 (1) ◽  
pp. 18-24
Author(s):  
P. Salomi ◽  
D. Mahendra Nayak ◽  
T. Vimalakannan ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Isocratic Mode ◽  
Good Percentage

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Guaifenesin and Dextromethorphan was successfully achieve THERMO, C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1M KH2PO4: Methanol (60:40) at a flow rate of 1.0ml/min and eluate was monitored at 280nm, with a retention time of 3.259 and 4.164 minutes for Guaifenesin and Dextromethorphan respectively. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Guaifenesin and 50µg/ml to150 µg/ml for Dextromethorphan. The values of the correlation coefficient were found to 0.999 for Guaifenesin and 1for Dextromethorphan. respectively. The LOD and LOQ for Guaifenesin were found to be 0.597 and 1.991 respectively. The LOD and LOQ for Dextromethorphan were found to be 0.1072 and 0.3572 respectively. This method was found to be good percentage recovery for were found to be 99 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.

scholarly journals Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

2018 ◽  
Vol 1 (1) ◽  
pp. 12-21
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Isocratic Mode

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

scholarly journals Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

2018 ◽  
Vol 1 (1) ◽  
pp. 12-21
Author(s):  
V Pavan Kumar ◽  
B Ramadevi ◽  
Shaik Karishma ◽  
P Divya ◽  
B Sivagami ◽  
...  
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Isocratic Mode

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

scholarly journals Development and Validation of RP-HPLC method for Simultaneous Estimation of Metformin and Pioglitazone

2017 ◽  
Vol 5 (01) ◽  
pp. 48-50
Author(s):  
Uttam Kumar Agrawal ◽  
Jeyabalan Govindasamy
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Drug Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation

A new simple, accurate ,precise and reproducible RP-HPLC method has been developed for simultaneous estimation of metformin and pioglitazone in bulk drug form using proper HPLC system. The mobile phase consists of phosphate buffer and acetonitrile in the ratio of 35:65 at pH 3.4.The detection wavelength was carried out at 228 nm. The method was linear over the concentration range for metformin 50-100 μg/mL and for pioglitazone 20-180 μg/mL. The recoveries of metformin and pioglitazone were found to be 100.5 and 98.7% respectively. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method method was successfully for the analysis of pharmaceutical formulations containing dosage form.

QBD BASED RP-HPLC METHOD FOR SCREENING AND ANALYSIS OF TELAPRAVIR AND 7 OTHER ANTIRETROVIRAL AGENTS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (02) ◽  
pp. 20-33
Author(s):  
N. S Kumar ◽  
◽  
R Kumaraswamy ◽  
S. Shantikumar ◽  
D. Paul
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Full Factorial

The present study describes the separation and simultaneous estimation of eight anti-retroviral drugs, namely, Telaprevir (TPV), Emtricitabine (ECB), Fosamprenavir (FANV), Tenofavir (TNF), Ritonavir (RNV), Raltegravir (RGV) and Oseltamivir (OSMV) and Zidovudine (ZDV) as an active pharmaceutical ingredient, by RP-HPLC method by applying the principles of Quality by Design (QbD). An application of DoE (Design of Experiments) full factorial design was used for initial screening and optimization. The final optimized method consists of separation being carried out on a Fortis C18 column (150 mm × 4.6 mm, 5μ particle size) using acetonitrile and 10 mm ammonium formate buffer (pH 3 adjusted with formic acid) using a gradient program. The quantitative evaluation was performed with a diode array detector at 251 nm and 230 nm with a flow rate of 1 mL min–1. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the International Conference on Harmonization (ICH) guidelines. The method is selective, precise, robust and accurate and can be used for routine analysis of pharmaceutical formulations in quality control and counterfeit screening.

scholarly journals A Validated RP-HPLC Method for Simultaneous Estimation of Atenolol and Indapamide in Pharmaceutical Formulations

2011 ◽  
Vol 8 (3) ◽  
pp. 1238-1245 ◽  
Author(s):  
G. Tulja Rani ◽  
D. Gowri Sankar ◽  
P. Kadgapathi ◽  
B. Satyanarayana
Keyword(s):  
Particle Size ◽  
Mobile Phase ◽  
Dosage Form ◽  
Orthophosphoric Acid ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of atenolol and indapamide from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, methanol and water (adjusted to pH 2.7 with 1% orthophosphoric acid) in the ratio of 80:20. The flow rate was 1 mL/min and effluent was detected at 230 nm. The retention time of atenolol and indapamide were 1.766 min and 3.407 min. respectively. Linearity was observed in the concentration range of 12.5-150 µg/mL for atenolol and 0.625-7.5 µg/mL for indapamide. Percent recoveries obtained for both the drugs were 99.74-100.06% and 98.65-99.98% respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of atenolol and indapamide from their combined dosage form.

scholarly journals Optimization of RP-HPLC method with UV detection for determination of ursodeoxycholic acid in pharmaceutical formulations

2020 ◽  
Vol 66 (1) ◽  
pp. 85-90
Author(s):  
Zhaklina Poposka Svirkova ◽  
Zorica Arsova-Sarafinovska ◽  
Aleksandra Grozdanova
Keyword(s):  
Ursodeoxycholic Acid ◽  
Flow Rate ◽  
Mobile Phase ◽  
Pharmaceutical Formulations ◽  
Gradient Elution ◽  
Hplc Method ◽  
Uv Detection ◽  
Rp Hplc ◽  
Ich Guidelines

Due to the low absorptivity of bile acids, the aim of this study was to develop and validate a simple and sensitive HPLC/UV method for quantification of ursodeoxycholic acid (UDCA) in pharmaceutical formulations. Effective separation was achieved on C18 end–capped column, with gradient elution of a mobile phase composed of 0.001 M phosphate buffer (pH 2.8±0.5) – acetonitrile mix, at flow rate 1.5 mL min-1, UV detection at 200 nm and injection volumes were 50 µL. The proposed HPLC method was fully validated according to the ICH guidelines and it was found to be simple, accurate, precise and robust. Key words: ursodeoxycholic acid, HPLC/UV, pharmaceutical formulations, validation

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 SIMULTANEOUS DETERMINATION OF TIGECYCLINE AND ITS POTENTIAL IMPURITIES BY A STABILITY-INDICATING RP-HPLC-UV DETECTION TECHNIQUE

2022 ◽  
pp. 75-82
Author(s):  
V. N. V. KISHORE ◽  
G. V. RAMANA
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Buffer Mixture ◽  
Bulk Drug ◽  
Tablet Dosage

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

scholarly journals Simultaneous estimation of gabapentin and methylcobalamin in bulk and pharmaceutical dosage form by RP-HPLC

2019 ◽  
Vol 9 (1) ◽  
pp. 170-174
Author(s):  
Anjali Bakshi ◽  
K Monika ◽  
Shweta Bhutada ◽  
M. Bhagvan Raju
Keyword(s):  
Particle Size ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Methylcobalamin from bulk and formulation. Chromatographic separation was achieved Isocratically on an Inertsil C18 column (150x4.6, 5µ particle size) using a mobile phase Buffer: Acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, effluents were detected at 264 nm and 10µl of sample was injected. Retention time of Gabapentin & Methylcobalamin was found to be 2.7 and 4.13 min respectively. Linearity of the method was in the concentration range of 25-150 µg for Gabapentin & 0.125-0.750 µg for Methylcobalamin. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision of the method was found to be less than 2%. The method was validated according to the ICH guidelines. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin & Methylcobalamin tablets and was fairly good in comparison with other methods. Keywords: Gabapentin, Methylcobalamin, HPLC.

Sign in / Sign up

Export Citation Format

Share Document