Stability Indicating RP-HPLC Method for Determination and Validation of Lurasidone HCL in Bulk and Pharmaceutical Dosage Forms

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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Development and Validation of Stability-indicating RP-HPLC Method for Coumarin Assay in Bulk Drugs and Pharmaceutical Products

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2013.6.3.11 ◽

2013 ◽

Vol 6 (3) ◽

pp. 2187-2192

Author(s):

S. Lakshmana Prabu ◽

S Thiyagarajan ◽

P Balan ◽

T N K Suriyaprakash ◽

Sharavanan S P

Keyword(s):

Linear Regression Analysis ◽

Analysis Data ◽

Pharmaceutical Products ◽

Dosage Forms ◽

Hplc Method ◽

Pharmaceutical Dosage Forms ◽

Stability Indicating ◽

Rp Hplc ◽

Development And Validation ◽

Simple Economic

A simple, economic, selective, precise, rapid and reproducible stability indicating HPLC method for the analysis of coumarin (CMN) in bulk drugs and from pharmaceutical formulation has been developed and validated. Separation was achieved on a symmetry C18 column using a mobile phase consisting of a mixture of methanol:water in the ratio of (70:30%v/v) at a flow rate of 1ml/min with detection at 276 nm. Linear regression analysis data for the calibration revealed a good linear relationship between response and concentration in the range 2 μgml-1 to 14 μg ml1 of CMN; the correlation coefficient was 0.999. The LOD and LOQ were 30 and 100 ng ml-1 respectively. The method was validated for accuracy, precision, recovery, reproducibility, specificity, robustness and degradation studies. The statistical analysis showed the method to be precise, reproducible, selective, specific and accurate for analysis and estimation of coumarin in bulk drugs and pharmaceutical dosage forms.

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

INDIAN DRUGS ◽

10.53879/id.52.07.10346 ◽

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.

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