scholarly journals RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations

2012 ◽  
Vol 9 (1) ◽  
pp. 35-42 ◽  
Author(s):  
A. Patnaik ◽  
S. S. Panda ◽  
S. Sahoo ◽  
V. J. Patro
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Uv Visible ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Quantitative Hplc

A simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA), PUMP (LC-IOAT) and (LC-IOATvp). Phenomenex C8, 5 μm, 25 cm × 4.6 mm i.d. column was used in the study. The mobile phase of ACN: Acetate buffer= 6.5:3.5 of pH 3 were used in this study. The conditions optimized were: flow rate (1 mL/minute), wavelength (222 nm) and run time was 20 min. Retention time was found to be 3.08 min. The linearity was found to be in the concentration range of 10-100 μg/mL. The developed method was evaluated in the assay of commercially available tablet moni containing 10 mg of montelukast. The amount of drug in tablet was found to be 10.34 mg/tab for the brand. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug. By using the method, stability of the drug has been studied.

scholarly journals RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

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.

RP-HPLC Method Development and Validation for the simultaneous estimation of Atazanavir sulphate and Ritonavir in bulk and tablet dosage form

2014 ◽  
Vol 1 (3) ◽  
pp. 50
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Jambulingam Munusamy ◽  
Saravanakumar Sengodan ◽  
Kamalakannan Danapal ◽  
Haritha D Siva Ganga Lakshmi ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage
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