Koduru, S., Kumar T, H., Mitta, C., Kalepu, S., Bairam, R. (2023). UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM. test, 46(1), 141-156. doi: 10.21608/bfsa.2023.300773
Swathi Koduru; Hemant Kumar T; Chaitanya Mitta; Swathi Kalepu; Ravindar Bairam. "UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM". test, 46, 1, 2023, 141-156. doi: 10.21608/bfsa.2023.300773
Koduru, S., Kumar T, H., Mitta, C., Kalepu, S., Bairam, R. (2023). 'UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM', test, 46(1), pp. 141-156. doi: 10.21608/bfsa.2023.300773
Koduru, S., Kumar T, H., Mitta, C., Kalepu, S., Bairam, R. UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM. test, 2023; 46(1): 141-156. doi: 10.21608/bfsa.2023.300773

UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM

Bulletin of Pharmaceutical Sciences Assiut University
Volume 46, Issue 1, June 2023, Pages 141-156    PDF (1.02 M)
Document Type: Original Article
DOI: 10.21608/bfsa.2023.300773
Authors
Swathi Koduru1; Hemant Kumar T* 2; Chaitanya Mitta1; Swathi Kalepu3; Ravindar Bairam4
1Department of Pharmaceutical Analysis, Bojjam Narasimhlu College of Pharmacy for Women, Vinay Nagar, Saidabad, Hyderabad – 500059, Telangana, India
2Department of Pharmaceutical Technology, NSHM Institute of Health Sciences, Kolkata, West Bengal 700053, India
3Department of Pharmaceutical Chemistry, Bojjam Narasimhlu College of Pharmacy for Women, Vinay Nagar, Saidabad, Hyderabad – 500059, Telangana, India
4Department of Pharmaceutical Analysis, Srikrupa Institute of Pharmaceutical Sciences, Velikatta, Siddipet-502277, Telangana , India
Abstract
A rapid, accurate, and precise HPLC approach for quantifying calcium orotate in capsule dosage form was developed and validated. As optimum conditions for analysis, a C8 column (250 mm x 4.6 mm, 5μ) was used as the stationary phase, with a mobile phase of 65:35 v/v acetonitrile and 25 mM potassium dihydrogen phosphate buffer (pH 4.7) at a flow rate 1 ml/min and detected at 254 nm. The method showed a 0.999 correlation and an excellent linear response throughout a concentration range of 15–90 μg/ml. Retention lasted for 3.186 minutes. Validation of the method done as per the requiremnts of ICH and  subjected to oxidation, photolysis, heat, acid, alkali hydrolysis, and water stress. Degradation byproducts did not affect the ability to detect calcium orotate, hence the approach is stability indicating. The approach may be used to determine calcium orotate in pharmaceutical capsule dose form since the findings of the research were within the parameters of ICH standards.
Keywords
Calcium orotate; HPLC; stability-indicating
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