Improved UV-Visible Spectrophotometric Analytical Method Development and Validation for Precise, Efficient and Selective Quantification of Atorvastatin Calcium in Bulk Form

DOI:

https://doi.org/10.37285/ijpsn.2023.16.5

Authors

  • Om M Bagade
  • Priyanka E. Doke Department of Pharmaceutics, D. Y. Patil International University School of Pharmacy, Akurdi, Pune-410044, Maharashtra, India.
  • Shashikant N Dhole 3Department of Pharmaceutics, PES Modern College of Pharmacy (For Ladies), Moshi, Pune-412105,
  • Praveen D Chaudhari Department of Pharmaceutics, PES Modern College of Pharmacy, Nigdi, Pune-411044, Maharashtra, India.

Abstract

Introduction: The quantification of atorvastatin calcium in bulk form has been created using an Ultra Violet (UV) Spectrophotometric technique. 

Objective: In the present study, a novel UV-spectroscopic method for calcium quantification of atorvastatin in bulk form was developed and validated.

Method: Various ratios of methanol and distilled water were investigated during the development of the analytical procedure; nevertheless it was found that the drug/actives was soluble in methanol: water (50:50). Scanning in the 200-400 nm range revealed that the detection wavelength (max) with 10 μg/ml was 246 nm. 

Result: According to the validation results, excipients in the pharmaceutical dosage form had no impact on the analysis. The average content percentages were 97.95±1.66 per cent and 98.42±0.91 per cent, respectively. The percentage Assay determination of the marketed pill was 99.340.3361%. The recovery percentages were 99.94±0.076 per cent and 99.98±0.079 per cent, respectively. Furthermore, robustness was discovered to be 99.76±0.367 per cent to 98.88±0.305 per cent.

Conclusion: The method was evaluated for analytical solution stability, specificity, linearity, accuracy, range, precision, repeatability, and robustness. Statistics and specificity studies were used to validate the investigation's findings. This investigation demonstrated the method's applicability for routine atorvastatin calcium estimation in tablet and bulk dosage forms.

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Keywords:

Atorvastatin calcium, Tablet dosage form, Quantification, Stability, Validation, ICH guidelines

Published

2023-09-15

How to Cite

1.
Bagade OM, Doke P, Dhole SN, Chaudhari PD. Improved UV-Visible Spectrophotometric Analytical Method Development and Validation for Precise, Efficient and Selective Quantification of Atorvastatin Calcium in Bulk Form. Scopus Indexed [Internet]. 2023 Sep. 15 [cited 2024 Feb. 26];16(5):6966-75. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/2410

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Research Articles

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