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.

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 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.

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

2010 ◽  
Vol 3 (2) ◽  
pp. 978-986
Author(s):  
Wamorkar V V ◽  
C S Ramaa ◽  
Manjunath S Y ◽  
V Malla Reddy
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Good Resolution ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Different Levels

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND EMPAGLIFLOZIN

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.

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

DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (09) ◽  
pp. 53-59
Author(s):  
Girija Dandu ◽  
Basu Venkateswara Reddy
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Grade Water ◽  
Development And Validation

The present study describes the development and validation of a new stability indicating RP-HPLC method for simultaneous estimation of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase YMC column (4.6 x 250mm, 5μm).The mobile phase used was mixture of HPLC grade water acetonitrile (70:30V/V) at flow rate of 1ml/ min in isocratic mode and detection was carried out using PDA detector at 244nm.The developed method showed a good linearity in the range of 100-500μg/mL for elbasvir and 200-1000 μg/mL for grazoprevir with regression co-efficient of 0.999 for both the drugs. The % recovery of drugs was found to be 100.1% for elbasvir and 100.38% for grazoprevir. The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.

scholarly journals Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation

2018 ◽  
Vol 34 (5) ◽  
pp. 2554-2561
Author(s):  
D. China Babu ◽  
C. Madhusudhana Chetty ◽  
S. K. Mastanamma
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A selective, sensitive RP-HPLC method was developed for the simultaneous estimation of the Ertugliflozin (ETR) and Sitagliptin (SGT) in bulk and its dosage form. The separation and determination was carried on water’s C18 column capacitate (250X4.6 mm, 5 µm particle size), retention times of Ertugliflozin and Sitagliptin were found to be 2.39 and 4.60 min respectively. The wavelength was fixed at 215nm with PDA detection. The mobile phase was consisted mixture of 0.5 mM potassium dihydrogen ortho phosphate buffer: Methanol in the ratio of 55:45 v/v, pH 5.3 was adjusted with HCl and flow of mobile phase was maintained 1mL/min. The calibration curve was linear and regression co-efficient (R2) value found to be 0.999 and concentration ranging from 37.5-112.5 and 250-750 µg/mL for Ertugliflozin & Sitagliptin respectively. The quantization limit and detection limit of the method were found 0.1 & 0.3 µg/ml and 0.4&1µg/ml for Ertugliflozin & Sitagliptin.

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

2018 ◽  
Vol 1 (1) ◽  
pp. 13-17
Author(s):  
V Pavan Kumar ◽  
T Supriya ◽  
B Sivagami ◽  
R Sireesha ◽  
R Charan Kumar ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Analysis ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A simple, accurate, rapid and precise method was developed for the simultaneous estimation of Ibuprofen and Diphenhydramine in Pharmaceutical dosage form. Chromatogram was run through Inertsil ODS (250x4.6mm) 5µ. Mobile phase used was Acetonitrile and Phosphate buffer (45:55) at a flow rate of 1.0 ml/min and detection wavelength was found to be 260 nm. The retention time was found to be 2.32 min and 2.93 min for Ibuprofen and Diphenhydramine respectively. The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2), accuracy (98-102%), specificity, LOD, LOQ values in accordance with ICH guidelines. The developed method is applicable for routine quality control analysis of selected combined dosage forms.

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.

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