Validated Photodiode Array Based Stability Indicating RP-HPLC Method for Simultaneous Estimation of Cinnarizine and Domperidone Maleate in Tablet Dosage Form

Author:

B. Patel Ashok1,M. Gol Akshat2,M. Akhiyaniya Sonal2,J. Vyas Amitkumar2,I. Patel Ajay2,V. Dudhrejiya Ashvin2

Affiliation:

1. Government Pharmacy College, Gandhinagar, Gujarat, India. Postal Code: 382027.

2. B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dam, Rajkot, Gujarat, India, Postal Code: 360003.

Abstract

For the simultaneous measurement of Cinnarizine and Domperidone Maleate in bulk and tablet dosage form, a accurate, reliable, robust, and cost-effective RP-HPLC method is developed. Chromatographic separation was accomplished using a mobile phase of Acetonitrile: 10mM Potassium dihydrogen phosphate (pH 3.0) (70:30% v/v) in an isocratic elution mode at a flow rate of 1mL/min on a Neuclosil C18 (25cm×4.6mm, 5µm) column at a wavelength of 271nm. Acidic, basic, oxidative, thermal, and photolytic stress environments were used to degrade the drugs. Cinnarizine and Domperidone Maleate were found to have linearities of 8–48μg/mL and 7.6–45.6 μg/mL, respectively. For both medicines, a % recovery of 99–101 was discovered. This method was validated as per ICH (Q2R1) guideline.

Publisher

A and V Publications

Subject

Pharmacology (medical),Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference43 articles.

1. Rang HP, Dale MM, Ritter RJ. Rang &Dales's Pharmacology. Elseveir Publication. 2012.

2. Indian Pharmacopoeia 7th edn., Government of India Ministry of Health & Family Welfare, Indian Pharmacopoeial Commission, Ghaziabad, 2014, Vol. II, pp. 1397-1398, 1613-1614.

3. Vyas AJ, Rathod N, Patel AI, Prajapati R, Patel NK, Patel AB. Analytical Method Development And Validation Of Stability Indicating Method And Related Substance By Using RP-HPLC Of Drug Substance. Pharma Science Monitor. 2017; 8(2): 409-419.

4. Vyas AJ, Taviyad M, Patel NK, Chotaliya UJ, Singh S, Patel AB, Patel AI. Chromatographic Method Development And Validation For Related Substance. Pharma Science Monitor. 2017; 8(2): 32-39.

5. Patel AI, Prajapati KB, Vyas AJ, Patel AB, Patel NK, et al. Determination and validation of phthalate impurities in milk by UV-spectrophotometry method. Pharma Science Monitor. 2021; 10(4): 49-58.

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