scholarly journals Comparison of the Robustness of Spectrophotometric Method and High-Performance Liquid Chromatographic Method for the Determination of Pioglitazone in Solid Dosage Form

Author(s):  
Sara Zahid ◽  
Fatima Zahid ◽  
Asma Ahmed ◽  
Waqas Safir

Pioglitazone is a drug that reduces the amount of glucose (sugar) in the blood. It is included in the class of anti-diabetic drugs called “thiazolidinedione” that are used in the treatment of type II diabetes. It attaches to the peroxisomes proliferated- activated receptor gamma (PPARϒ) on tissues throughout the body and causes the cells to become more sensitive to insulin. As a result, more glucose is removed from the blood.The aim of the study is more precisely to find out the better analytical method for the quantitative measurement of the content of pioglitazone in commercially available drugs using two analytical methods i-e Spectrophotometric method and HPLC method.The analytical method for the pioglitazone hydrochloride was developed by HPLC, and then validated the method according to compendial requirements. Pioglitazone in various Dowglit and Gliden tablets was determined by this developed methodPrecision, Accuracy and stability of Pioglitazone was checked which came out to be100.40% and 100.19% respectively. The analysis of pioglitazone hydrochloride in solid dosage form using the HPLC method shows the results are more sensitive, accurate, validated and economical and can be easily applied to raw materials and finished goods compared to the Spectrophotometer method.

2010 ◽  
Vol 7 (3) ◽  
pp. 947-952 ◽  
Author(s):  
Rajesh Sharma ◽  
Ganesh Prasad Mishra ◽  
Subhash Chandra Chaturvedi

A simple, sensitive, precise, accurate, rapid and reproducible reverse phase high performance liquid chromatographic procedure is developed for simultaneous determination of rabeprazole sodium and itopride hydrochloride in solid dosage form. The mobile phase used was a combination of acetonitrile: buffer (35:65 v/v) and the pH was adjusted to 7.0 ± 0.1 by addition of triethylamine. The detection of the capsule dosage form was carried out at 266 nm and a flow rate employed was 1 mL/min. Linearity was obtained in the concentration range of 2 to 16 μg/mL of rabeprazole sodium and 5 to 55 μg/mL of itopride hydrochloride with a correlation coefficient of 0.9992 and 0.9996 respectively. The results of the analysis were validated statistically and recovery studies confirmed the accuracy of the proposed method.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (03) ◽  
pp. 39-45
Author(s):  
A Sherje ◽  
A. Sonalkar ◽  

A reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of olmesartan medoxomil (OLME) and chlorthalidone (CHLOR) in tablet dosage form. The analysis was performed on Inertsil ODS C18 (250 x 4.6 mm, 5 μ) using KH2PO4 phosphate buffer (pH) and acetonitrile as mobile phase in the proportion of 60: 40 v/v at flow rate of 1.0 mL/min. Detection of drugs was carried out in isocratic mode using UV detector at 275 nm. The retention time of OLME and CHLOR was 13.9 ± 0.1 min. and 4.4 ± 0.5 min., respectively and the total run time was 20 min. The method was validated according to the requirements of the United States Pharmacopeia. The percentage recoveries was found to be in the range of 98.9 - 100.7%. The method was successfully applied to the assay of OLME and CHLOR in tablet dosage form.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 63-68
Author(s):  
R. Raut ◽  
◽  
A. Patil ◽  
V. K Munipalli ◽  
M. Patel ◽  
...  

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.


INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  

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.


1970 ◽  
Vol 3 (1) ◽  
pp. 49-53 ◽  
Author(s):  
Gaurav Patel ◽  
Sanjay Patel ◽  
Dhamesh Prajapiti ◽  
Rajendra Mehta

A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in combine dosage form. Amlodipine Besylate (AML) is a long acting calcium channel blocker and in the treatment of CVS disorder. Hydrochlorothiazide (HCT) is a diuretic and antihypertensive. The mobile phase used was a combination of Water: Methanol (70:30). The detection of the combined dosage form was carried out at 245nm and a flow rate employd was 0.5ml/min. The retention time for Amlodipine Besylate and Hydrochlorothiazide was found to be 6.95 and 2.65 min respectively. Linearity was obtained in the concentration range of 6 to 18μg/ml of Amlodipine Besylate and 6 to 18μg/ml of Hydrochlorothiazide with a correlation coefficient of 0.997 and 0.9974. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (5 μm size, 250mm, 4.6mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method is precise, selective and rapid for simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in routine analysis. Key Words: Simultaneous Estimation; Amlodipine Besylate; Hydrochlorothiazide; HPLC. DOI: 10.3329/sjps.v3i1.6798S. J. Pharm. Sci. 3(1): 49-53


2017 ◽  
Vol 4 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Ramesh Jayaprakash ◽  
Senthil Kumar Natesan

A simple, economic, accurate, sensitive, specific and precise stability indicating reverse phase high performance liquid chromatographic [RP-HPLC] method for the determination of Regorafenib in pure and tablet dosage from was developed and validated. The chromatographic separation was carried out using Phenomenex Luna-C18 column (4.5x250 mm; 5 µm particle size) as a stationary phase and methanol: acetonitrile: water (55:25:20 v/v/v) as a mobile phase. The flow rate of 1 mL/min was used with PDA detection at 275 nm. The retention time of Regorafenib was 2.480 min. RP-HPLC method was developed with linearity range of 40-240 µg/mL of Regorafenib. The correlation coefficient [r2] was found to be 0.9999. The assay results obtained was in good agreement with the corresponding labeled amount by developed method within range of 98.83 ± 0.6937. Accuracy of the method was confirmed by recovery studies and the recoveries were found to be between 99.61 % and 100.22 %, the corresponding %RSD was found to be 0.2029. Precision, LOD, LOQ, specificity, robustness and ruggedness were performed as per ICH Q2(R1) guidelines and were within the acceptance criteria. This method can be conveniently used to detect the possible degradation product in the dosage form of Regorafenib during stability studies (acidic, alkaline, oxidative, thermal and photolytic). The method proved to be effective on the analysis of stressed marketed tablet formulation.


2012 ◽  
Vol 10 (2) ◽  
pp. 67-70
Author(s):  
Abdullah Al Masud ◽  
Mohammad Saydur Rahman ◽  
Towfika Islam ◽  
Saki Sultana ◽  
Moynul Hasan ◽  
...  

A simple, reproducible and efficient reversed phase high performance liquid chromatographic (RPHPLC) method has been developed for the estimation of a recently approved anti allergic drug, amlexanox in oral paste dosage form. The separations were carried out on a Zorbax Eclipse XBD, C18 column (150 x 4.6 mm; 5?m) at a flow rate of 1.50 ml/min. by using mobile phase comprising of mixed buffer (pH adjusted to 6.50) and methanol (50:50 v/v). The injection volume was 10 ?l and the peaks were detected at 244 nm. The linear dynamic range found to be in the concentration range of 15-35 ?g/ml and coefficient of correlation was found to be 0.999. The %RSD value was below 2.0 for intra-day and inter-day precision which indicated that the method was highly precise. The LOD (Limit of detection) and LOQ (Limit of quantitation) were found to be 3.8 ng/ml and 12.5 ng/ml, respectively which revealed that the method was highly sensitive. The percentage recovery of amlexanox ranged from 99.31 to 99.75%, indicating the accuracy of the method and absence of interference from the excipients present in the formulation. The proposed method was simple, fast, accurate and reproducible and hence can be applied for routine quality control operations of amlexanox in oral paste dosage form. Key words: Amlexanox, Anti allergic, RP-HPLC, LOD, LOQ. DOI: http://dx.doi.org/10.3329/dujps.v10i2.11782 Dhaka Univ. J. Pharm. Sci. 10(2): 67-70, 2011 (December)


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