Development and validation of stability indicating RP-HPLC method for estimation of Perindopril Erbumine and Indapamide in bulk and pharmaceutical dosage form

Tabrej Mujawar; Sufiyan Ahmad; Salman Khatik; Manoj Tare; Dwarkadas Baheti; Asmita Gaikwad; Gauri Ghangale

doi:10.53730/ijhs.v6nS6.11703

Authors

Tabrej Mujawar Department of Pharmacology, Gangamai College of Pharmacy, Nagaon, Dist. Dhule, Affiliated to Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India
Sufiyan Ahmad
sufipharm1712@gmail.com
Department of Quality Assurance, Gangamai College of Pharmacy, Nagaon, Dist. Dhule, Affiliated to Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India
Salman Khatik Department of Quality Assurance, Gangamai College of Pharmacy, Nagaon, Dist. Dhule, Affiliated to Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India
Manoj Tare Department of Pharmaceutics, Sitabai Thite College of Pharmacy, Shirur (Ghodnadi), Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Dwarkadas Baheti Department of Pharmacognosy, Sitabai Thite College of Pharmacy, Shirur (Ghodnadi), Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Asmita Gaikwad Department of Pharmaceutical Chemistry, Sharadchandra Pawar College of Pharmacy, Otur, Tal. Junnar, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Gauri Ghangale Department of Pharmacognosy, Amrutvahini College of Pharmacy, Sangamner, Dist. Ahmednagar, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India

Keywords:

perindopril Erbumine, Indapamide, validation, stability, degradation, RP-HPLC

Abstract

Background: Perindopril erbumine (PE) and Indapamide (IND) in combination were proven to have a synergistic antihypertensive impact when compared with the use of each component alone. Objectives: Therefore, a new simple, selective, precise, and stability indicating RP- HPLC method for analysis of Perindopril erbumine (PE) and Indapamide both in a bulk and in pharmaceutical formulation has been developed and validated. Methods: RP ‑ HPLC method, Younglin (S.K.) Gradient System UV Detector and C₁₈column with 250mm x 4.6 mm i. d. and 5μm particle size acetonitrile 70+ water with OPA 30 was used as the mobile phase for the method. The detection wavelength was 215 nm and flow rate was 1 ml/min. Results: In the developed method, the retention time of Perindopril erbumine (PE) and Indapamide were found to be 5.4833 min and 9.4500min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Conclusion: Hence the method was found to be simple, accurate, precise, economic and reproducible. The forced degradation studies proved stability indicating power of the method.

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