Informatics Publishing Limited

S. Lakshmana Prabu ¹, N. Sivagurunathan ¹, C. Dinesh Kumar ¹, S. G. Vasantharaju ¹, B. Meenashi Vanathi ²

Affiliations
1 Manipal College of Pharmaceutical Sciences, Manipal University, Manipal- 576104, Karnataka, IN
2 Shree Devi College of Pharmacy, Mangalore, Karnataka, IN

Abstract

A simple, rapid and accurate RP-HPLC method was developed for the determination of racecadotril in solid pharmaceutical dosage form. The method showed a linear response for concentrations in the range 10-200 μg/ml using methanol: water (80:20 v/v) as the mobile phase with detection at 231 nm and a flow rate of 1.2 ml/min. Solution concentrations were measured at a weight basis to avoid the use of an internal standard. The method was statistically validated for accuracy, precision, linearity, range, ruggedness, robustness, forced degradation, solution stability, and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be 0.53. Due to the simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.

Keywords

Racecadotril, HPLC, Degradation Studies.

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S. G. Vasantharaju ¹, Mishra Akanksha ¹, Arumugam Karthik ¹, Musmade P. Prashant ¹, Udupa Nayanabhirama ¹, K. M. Bhat ¹

Affiliations
1 Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, IN

Abstract

A simple, rapid, and accurate RP-HPLC method was developed for the determination of tolterodine in solid pharmaceutical dosage form. The method showed a linear response for concentration in the range of 1-15μg/ml using acetonitrile:potassium dihydrogen phosphate (50:50,v/v) as the mobile phase with detection at 284 nm and a flow rate of 1ml/min. The method was statistically validated for accuracy, precision, linearity, range, robustness, and stock solution stability. Recovery studies of the dosage form were also carried out and the mean recovery was found to be 98.35±1.01 %. Due to the simplicity, rapidity, and accuracy the method could be used for routine quality control analysis.

Keywords

Tolterodine, HPLC, Degradation Studies.

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Ragini V. Mane ¹, Kritika Patel ¹, Gude Sai Sushmitha ¹, S. G. Vasantharaju ¹

Affiliations
1 Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, IN

Abstract

An effective and simple UV-Spectrophotometric method was developed and validated for the quantification of Diclofenac sodium in tablets. The maximum absorption was found to be 282nm by using methanol as the solvent. The linearity range was 6-21 μg/ml and the correlation coefficient (r²) was found to be 0.9985. The method was accurate, precise, and robust with %RSD below 2%. The LOD and LOQ was found to be 0.0885μg/Ml and 0.250μg/mL respectively. Sandel’s sensitivity was found to be 0.000002 μg/mL. Assay and accuracy of the tablets were about of the acceptance criteria range as per the ICH guidelines.

Keywords

UV Spectrometry, Diclofenac Sodium, Tablets, Validation, ICH Guidelines.

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