DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR THE ESTIMATION OF PERINDOPRIL AND INDAPAMIDE
Keywords:Perindopril arginine, Indapamide, HPTLC, Stability indicating method
Objective: To develop a validated stability indicating HPTLC method for determination Perindopril and Indapamide.
Methods: The method was based on the separation of two drugs on plates precoated with silica gel 60 F254 using Dichloromethane: Methanol: Glacial acetic acid in the ratio of 9.5:0.5:0.1 v/v/v as mobile phase followed by scanning in absorbance mode at 215 nm.
Results: The optimized chromatographic conditions gave compact spot for Perindopril and Indapamide at Rf value of 0.30 Â± 0.02 and 0.60 Â± 0.02 respectively. The calibration curve was found to be linear in range of 1000-5000 ng/band and 200-1000 ng/band for perindopril and indapamide respectively. The limit of detection and quantification were found to 164 ng/band and 491 ng/band for Perindopril and 41.41 ng/band and 125.49ng/band for Indapamide. The method has been successfully applied to tablets and was validated according to ICH Harmonized Tripartite guidelines.
Conclusion: A new sensitive, simple, rapid and precise high performance thin layer chromatographic (HPTLC) method has been developed and validated for simultaneous determination of Perindopril and Indapamide in pharmaceutical dosage form. The proposed method can be applicable for simultaneous determination of Perindopril and Indapamide in bulk and formulation.
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