scholarly journals Development and validation of chemometric assisted analytical methods for simultaneous estimation of Atorvastatin calcium and Aspirin in capsule dosage form

2019 ◽  
Vol 10 (3) ◽  
pp. 1692-1697
Author(s):  
Keerthisikha Palur ◽  
BharathiKoganti ◽  
Sreenivasa Charan Archakam

To develop two Chemometric-assisted analytical methods like UV spectrophotometry and RP-HPLC methods for the quantification of Atorvastatin calcium (ASC) and Aspirin (APN) in the capsule dosage form. Chemometric models used in UV spectrophotometry were Principal component regression model (PCRM) and Partial least-square regression (PLSR). Both the models were applied for the drugs in the calibration ranges of 4-20 and 30-150 μg/mL for ASC and APN respectively. Total of nineteen laboratory prepared mixtures were used for calibration and prediction set of the models. In addition, RP-HPLC method by using chemometric approach for was developed using C18 column at room temperature with a mobile phase of acetonitrile: methanol: triethylamine (53.1:11.9:35 v/v/v), pH- 3.0, with detection at 275 nm. PCRM and PLSR models were evaluated by statistical parameters and RP-HPLC method was optimized by using Response surface methodology. The developed methods like UV and RP-HPLC by using chemometrics showed almost similar results and both the methods can be used for their analysis.

Author(s):  
Santosh V. Gandhi ◽  
Deepak Patil ◽  
Atul A. Baravkar

In present work, chemometric-assisted UV spectrophotometric methods as well as RP-HPLC method were developed for the simultaneous estimation of Ofloxacin and Tinidazole in their combined pharmaceutical dosage form. The two chemometric methods i.e. principle component regression (PCR) and partial least square regression (PLS) were successfully applied to quantify each drug in mixture using UV absorption spectra in range of 280 to 320nm at ∆λ of 0.5nm. Chemometric model development was done using 24 binary mixture solutions and 12 solutions were used for validation of model. The chemometric-assisted analysis does not require any prior separation step. In addition, RP-HPLC method was also developed using THERMOSIL C18 column with a mobile phase consisting ofAcetonitrile: Phosphate Buffer (85:15% v/v), flow rate of 1 ml/min and quantification was achieved using UV detector at 300 nm. The methods were successfully applied for the simultaneous determination of these drugs in synthetic mixture. The results obtained for analysis by PCR and PLS methods were compared with RP-HPLC method and a good agreement was found.


Author(s):  
Pankaj Yadav ◽  
Mohamad Taleuzzaman ◽  
Pradeep Kumar

A rugged robust RP-HPLC method has been developed and validated for the simultaneous quantification of Aspirin (ASP), Atorvastatin calcium (ATO) and Clopidogrel bisulphate (CLO) in a combined dosage form. Optimized mobile phase composition of 25 mM KH2PO4: Methanol (20:80% v/v) pH 3.0 (adjusted with 20% o-phosphoric acid) isocratic mode with flow rate of 1 ml  min-1, detection at 230 nm. Employed Princeton SPHER C18 (150 x 4.6 mm i.d. 5 µm) column for separation at ambient temperature with an isocratic flow. The linearity of each drug across the range of 0.5-32 µg/ml with correlation coefficient for ASP, ATO, and CLO in value of 0.979, 0.988 and 0.989 respectively. The retention time (min.) for ASP, ATO and CLO were found 1.85, 3.04 and 6.91 respectively. Limit of detection (LOD) of ASP, ATO and CLO - 0.04, 0.04, 0.08 (μg ml-1) respectively and Limit of Quantification (LOQ) of ASP, ATO and CLO- 0.14, 0.13, 0.28 (μg ml-1) in order. Performed analysis of marketed tablet formulation ASP (Ecosprin-75 mg), ATO (Aztor®40- 40 mg), CLO (Clopivas- 75 mg) found percentage recovery for ASP (99.93), ATO (100.00) and CLO (99.87). Performed stability studies found satisfactory results. Developed method has been validated, results of different parameter found in acceptable range. Chromatogram peaks are resolve, symmetric shape and without interference.


2019 ◽  
Vol 9 (1) ◽  
pp. 175-179 ◽  
Author(s):  
BANGARUTHALLI JAGIRAPU ◽  
U Harini ◽  
M Divya ◽  
P Sushma

A new method has been established for the simultaneous estimation of Telmisartan and Atorvastatin calcium by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Telmisartan and Atorvastatin calcium by using boston ODS C18 column, flow rate was 1.0ml/min, mobile Phase consists of methanol:Acetonitrile:buffer in ratio of 35:25:40. Detection wave length was 235nm.The instrument used was SHIMADZU HPLC auto sampler. The retention time of Atorvastatin calcium and Telmisartan was found to be 2.350 and 3.490 minutes respectively. The analytical method was validated according to ICH guidelines (ICH Q2b). The correlation coefficient (r2) was found to be 0.997 and 0.999 for Telmisartan and Atorvastatin calcium respectively. % mean recovery was found to be 100.943% and 100.576% for Telmisartan and Atorvastatin calcium respectively. %RSD for precision on replicate injection was 0.46 and 0.70 for Telmisartan and Atorvastatin calcium respectively. The validation study was found to be precise, robust, and repeatable. Keywords: Telmisartan, Atorvastatin calcium, ICH guidelines, Validation.


2012 ◽  
Vol 24 (1) ◽  
pp. 15-22 ◽  
Author(s):  
P. B. Deshpande ◽  
S. V. Gandhi ◽  
N. V. Gaikwad ◽  
K. S. Khandagle

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