scholarly journals Stability Indicating Analytical Method Development and Validation of Efavirenz Quantification by High Performance Liquid Chromatographic Technique

2011 ◽  
Vol 8 (4) ◽  
pp. 1498-1503 ◽  
Author(s):  
R. Kumar ◽  
M. Sharma ◽  
G. R. Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Chromatographic Technique ◽  
Stability Indicating ◽  
Stainless Steel Column ◽  
Development And Validation ◽  
Liquid Chromatographic

A stability-indicating high performance liquid chromatography (HPLC) method is developed for the quantification of efavirenz drug substance. Selected mobile phase is a combination of 50 volume of acetonitrile and 50 volume of 0.86% w/v solution of ammonium dihydrogen phosphate, pH adjusted to 3.0 with orthophosphoric acid. Optimized column is a stainless steel column packed with base deactivated octa decylsilyl silica gel and at 252 nm wavelength. Linearity of the method is found 40 μg/mL to 160 μg/mL with regression coefficient of 0.9995. The method is validated according to ICH guidelines.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Correlation Coefficients ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of abacavir sulphate (ABA) and lamivudine (LAM) in combined dosage form. Separation was performed on a C18 column [Agilent ODS UG 5 column, 250 mm x 4.5 mm], with methanol: water (50:50 V/V) isocratic elution using a flow rate of 1mL/min. Good sensitivity was observed with UV detection at 277 nm. After method development, the interference of other active compounds and excipients, repeatability and linearity, were investigated. Retention times of LAM and ABA were found to be 3.3 and 6.3 min, respectively. The method was validated over the range from 2.5-12.5 μg/mL for LAM and 5-25 μg/mL for ABA with correlation coefficients of 0.9997 and 0.9996, respectively. This method was shown to be accurate, robust, selective, linear, and repeatable and can be successfully employed in routine quality control for the simultaneous analysis of ABA and LAM in tablets.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HYDROCHLORIDE USING RAPID HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC TECHNIQUE

2018 ◽  
Vol 11 (11) ◽  
pp. 118
Author(s):  
Zubaidur Rahman ◽  
Vijey Aanandhi M ◽  
Sumithra M
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Sensitivity ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Chromatographic Technique ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of atomoxetine HCl (ATH) in bulk and formulations.Methods: The chromatographic development was carried out on RP-HPLC. The column used as Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size), with mobile phase consisting of methanol: water 80:20 V/V. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm.Results: The retention time was found to be 5.350 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 2–10 μg/mL with a regression coefficient of 0.9999. The method has proved high sensitivity and specificity.Conclusion: The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate which is useful for the routine determination of ATH in bulk drug and in its pharmaceutical dosage form.

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 RP-HPLC method for the Determination of Olanzapine in Bulk and Tablet Dosage form

2017 ◽  
Vol 10 (5) ◽  
pp. 281
Author(s):  
Sv Saibaba ◽  
Shanmuga Pandiyan P
Keyword(s):  
High Performance ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Reverse Phase ◽  
Relative Standard ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: To develop and validate reverse phase-high performance liquid chromatographic method for estimation of olanzapine in bulk and tablet dosage form.Methods: Chromatographic analysis was performed on XTerra C18 (150×3.5 mm inner diameter, 5 μm) column using a mobile phase consisting of buffer (potassium dihydrogen phosphate) and methanol (45:55% v/v) with a flow rate of 0.6 ml/minutes. The detection was carried out at 247 nm.Results: The calibration curve of olanzapine was linear in the range of 30-70 μg/ml. The mean % assay of marketed formulation was found to be 100.2%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%.Conclusion: The developed method is simple, precise and rapid, making it suitable for estimation of olanzapine in bulk and tablet dosage form.Keywords: Olanzapine, Reverse phase-high performance liquid chromatographic, Validation.

scholarly journals Analytical Method Development and Validation for the Estimation of Canagliflozin in Bulk and Formulation by RP- HPLC

2018 ◽  
Vol 10 (03) ◽  
Author(s):  
Darshan Bhatt ◽  
Padmini Thatavarthi ◽  
B. Rajkamal
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple and sensitive reverse phase high performance liquid chromatographic method was developed and successively validated for the estimation of Canagliflozin. In the new method, Canagliflozin separation was carried out by the nonpolar inertsil ODS-3 (250 × 4.6 mm, 5μ) column with a mobile phase composition of Ammonium acetate buffer (pH-4.5) and Acetonitrile in the ratio of 30:70% v/v. Canagliflozin was determined at 252 nm using UV detection and the compound was eluted at the retention time of 4.5 min. As per International Conference on Harmonization (ICH) guidelines, the method was validated and the parameters were precision, accuracy, linearity, limit of detection, limit of quantitation and robustness. The chromatographic method was accurate, linear, specific, precise and robust. The results of method concluded that the proposed RP-HPLC method is useful, convenient and reliable in regular analysis of Canagliflozin in bulk and its formulation

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 UV-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BESIFLOXACIN HYDROCHLORIDE

2017 ◽  
Vol 10 (5) ◽  
pp. 250 ◽  
Author(s):  
Bijit Saha
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Good Precision ◽  
Analyte Solution ◽  
Bulk Drug ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Liquid Chromatographic

Objectives: The objective of the present investigation was to develope and validates a new, rapid, accurate high performance liquid chromatographic (HPLC) method for the quantification of Besifloxacin Hydrochloride.Methods: Isocratic UV-HPLC separation was performed using a Zodiac C18 (150 X 4.6 mm) column, with 150 volume of Acetonitrile and 350 mL of Methanol in 500 mL buffer as mobile phase at a flow rate of 2 mL/min and UV detection at 295nm..Results: The sample found stable for 24 hours in analyte solution and compatible with nylon filter. The Beer’s law plots were found to be linear over the concentration range 70% to 130% with a correlation coefficient (r2) 0.9999 in diluent, phosphate buffer and simulated tear media. The %RSD was found less than 2% shows good precision, acceptable accuracy and reproducibility of the new method for the determination of Besifloxacin Hydrochloride.Conclusion: The method was validated as per the ICH guidelines. The method is accurate and can be applied for qualitative analysis of Besifloxacin Hydrochloride in bulk drug and in formulation.Keywords: Besifloxacin hydrochloride, High performance liquid chromatographic, Stress testing, Validation, Linearity, Accuracy, Precision.

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Ketorolac and Fluoromethalone in Ophthalmic Formulations

2017 ◽  
Vol 10 (5) ◽  
pp. 3815-3826
Author(s):  
Nisha D Patel ◽  
Maitri V. Sharma ◽  
Bhavesh Prajapati ◽  
Samir K Shah
Keyword(s):  
Formic Acid ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Water Ph ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of ketorolac and fluorometholone in its ophthalmic formulation. ODS-BP hyperchrome C18 having 250 mm × 4.6 mm × 5µm with mobile phase composed of 0.2% Formic acid and 0.2% of TEA in water (pH adjusted to 5.0 with Formic Acid): Methanol (40:60 v/v) at flow rate of 1.0 ml/min, detection wavelength at 230 nm. The retention times of ketorolac and fluorometholone were found to be 5.164 min and 2.969 min, respectively. Linearity was established for Ketorolac and fluorometholone in the range of 80-120 μg/mL and 16-24 μg/mL respectively. The percentage recoveries for ketorolac and fluorometholone were found to be in the range of 98-99% and 98-99% respectively. The LOD and LOQ for Ketorolac was found to be 5.14 and 15.5 μg/ml, and for fluorometholone 0.72 and 2.21 respectively.    

scholarly journals Development and Validation of RP-HPLC method for determination of Modafinil in bulk and dosage form(3ò¬

1970 ◽  
Vol 1 (4) ◽  
pp. 77-80
Author(s):  
Chusena Narasimha Raju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Swetha Karamsetty
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Pharmaceutical Journal ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed for the determination of Modafinil in bulk and dosage form. The separation was effective on a Hypersil ODS C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of Buffer:Acetonitrile in a ratio of 55:45 (v/v) at a flow rate of 1.0ml/min. The detection was made at 220nm. The retention time of modafinil was found to be 4.80±0.06 min. Calibration curve was linear over the concentration range of 20-120μg/ml of modafinil. The proposed method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid and thus found to be suitable for the quantitative analysis of modafi-nil in the bulk and dosage form.Key Words: Method development; validation; Modafinil; Tablets; Hypersil C18 Column; RP-HPLC.DOI: http://dx.doi.org/10.3329/icpj.v1i4.10062International Current Pharmaceutical Journal 2012, 1(4): 77-80 

Sign in / Sign up

Export Citation Format

Share Document