A validated stability‐indicating RP‐HPLC method for Dipyridamole in the presence of degradation products and its process‐related impurities in Pharmaceutical dosage forms

2021 ◽  
Author(s):  
Ravindra Mallavarapu ◽  
Naresh Kumar Katari ◽  
Thirupathi Dongala ◽  
Vijay Kumar Rekulapally ◽  
Vishnu Murthy Marisetti ◽  
...  
Keyword(s):  
Degradation Products ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Related Impurities ◽  
Rp Hplc

DEVELOPMENT AND VALIDATION OF AN IMPROVED STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF TROXIPIDE IN BULK AND TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (07) ◽  
pp. 18-22
Author(s):  
D. Gowrisankar ◽  
◽  
N.M Rao
Keyword(s):  
Degradation Products ◽  
Thermal Conditions ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Improved Stability ◽  
Degradation Studies ◽  
Tablet Dosage

An improved stability-indicating RP-HPLC method was developed for the estimation of troxipide in bulk and tablet dosage forms. Chromatographic separation of troxipide from its degradation products was achieved on Agilent Zorbax SB-CN (150 × 4.6 mm, 3.5 μm) using sodium phosphate buffer (pH was adjusted to 4.0 ±0.05) and acetonitrile in the ratio of 40:60 V/V, at a flow rate of 0.8 mL/min. This system was found to give compact peak for troxipide at 2.1±0.2 min. The detection was monitored at 260 nm. The linear regression data for the calibration plots showed good relationship with r2 = 0.99 ± 0.001. The method was validated for precision, linearity, accuracy and robustness according to International Conference on Harmonization (ICH) guidelines. The percentage RSD was found to be less than two, indicating high degree of accuracy and precision of the proposed RP-HPLC method. The drug was subjected to stress degradation studies under acidic, basic, oxidative and thermal conditions. The degradation studies reveal that purity angle was less than the purity threshold, so the peak was said to be pure. It means that products resulting from stress studies did not interfere with the detection of troxipide and the assay can thus be considered as stability-indicating. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining troxipide in bulk and in pharmaceutical dosage forms.

scholarly journals Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Cinacalcet Hydrochloride in Bulk and Their Formulations

2020 ◽  
Vol 10 (6) ◽  
pp. 6610-6618
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Cinacalcet Hydrochloride ◽  
Development And Validation ◽  
Tablet Dosage

A Simple, selective, accurate, precise, linear, and stability-indicating RP-HPLC method was developed and validated for the estimation of Cinacalcet hydrochloride in bulk and tablet dosage forms. Chromatographic separation was achieved on X-Terra Symmetry C18 (4.6 x 150mm; 5 m) with mobile phase containing Phosphate buffer: Acetonitrile (40:60 v/v) pH adjusted to 3.0 ±0.05 with diluted ortho-phosphoric acid. The flow rate was maintained at 0.9 mL/min. The eluent was monitored at 282 nm. Moreover, the retention time of Cinacalcet was 2.8 minutes. The method was validated for linearity, accuracy, precision, and robustness as per ICH guidelines. The developed method was found linear between 25-150 μg/ml, and the linear regression coefficient was 0.999. The % RSD values are less than 2 % indicating the accuracy and precision of the method. The percentage of recovery was obtained from 98-102%. The system suitability parameters were found to be within the limit. Forced degradation studies were conducted under various conditions. The proposed method is simple, rapid, precise, and accurate. It can be used for the quantitation of Cinacalcet hydrochloride in bulk and commercial pharmaceutical dosage forms.

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