ISSN 2394-5125
 

Research Article 


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM

Vasava Sarita C, Patel Pinkal H.

Abstract
Purpose: To develop and validate a novel reverse phase high performance liquid chromatographic
(RP-HPLC) method for the estimation of atorvastatin and vitamin D3 in pharmaceutical dosage form. The RPHPLC
Method has shown adequate separation of Atorvastatin Calcium and Vitamin D3 in Bulk and its synthetic
mixture.
Method: Chromatographic identification was achieved on Phenomenex C18 (250mm x 4.6mm 5μm particle
size) column with mobile phase using Acetonitrile: Methanol ratio of 75:25 v/v, pH 3.5 adjusted with orthophosphoric
acid and flow rate is 1.2 ml/min. Sample injection volume is 20 μl and detection wavelength at 252
nm. The developed HPLC method was validated according to International Conference on Harmonization (ICH)
Q2 (R1) guidelines.
Result: The retention time for Atorvastatin calcium and Vitamin D3 was obtained as 2.9 min and 16.6 min
respectively. The linearity of the proposed method was investigated in the range of 8-28 μg/ml and 2-7 μg/ml
for Atorvastatin calcium and Vitamin D3 respectively. Correlation coefficient was 0.9984 and 0.9955 for
Atorvastatin Calcium and Vitamin D3, respectively. The developed method was validated as per ICH guidelines,
for its accuracy, precision, LOD & LOQ.
CONCLUSION: The method was developed successfully and the results of developed method were found
satisfactory, thus the method is specific, rapid, simple and sensitive for estimation of Atorvastatin Calcium and
Vitamin D3.

Key words: Atorvastatin Calcium, Vitamin D3, RP-HPLC, Method Development, Validation


 
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Pubmed Style

Vasava Sarita C, Patel Pinkal H. ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. JCR. 2020; 7(16): 3128-3138. doi:10.31838/jcr.07.16.401


Web Style

Vasava Sarita C, Patel Pinkal H. ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. http://www.jcreview.com/?mno=132092 [Access: May 30, 2021]. doi:10.31838/jcr.07.16.401


AMA (American Medical Association) Style

Vasava Sarita C, Patel Pinkal H. ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. JCR. 2020; 7(16): 3128-3138. doi:10.31838/jcr.07.16.401



Vancouver/ICMJE Style

Vasava Sarita C, Patel Pinkal H. ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. JCR. (2020), [cited May 30, 2021]; 7(16): 3128-3138. doi:10.31838/jcr.07.16.401



Harvard Style

Vasava Sarita C, Patel Pinkal H (2020) ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. JCR, 7 (16), 3128-3138. doi:10.31838/jcr.07.16.401



Turabian Style

Vasava Sarita C, Patel Pinkal H. 2020. ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. Journal of Critical Reviews, 7 (16), 3128-3138. doi:10.31838/jcr.07.16.401



Chicago Style

Vasava Sarita C, Patel Pinkal H. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM." Journal of Critical Reviews 7 (2020), 3128-3138. doi:10.31838/jcr.07.16.401



MLA (The Modern Language Association) Style

Vasava Sarita C, Patel Pinkal H. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM." Journal of Critical Reviews 7.16 (2020), 3128-3138. Print. doi:10.31838/jcr.07.16.401



APA (American Psychological Association) Style

Vasava Sarita C, Patel Pinkal H (2020) ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN PHARMACEUTICAL DOSAGE FORM. Journal of Critical Reviews, 7 (16), 3128-3138. doi:10.31838/jcr.07.16.401