Method Devolopment and Validation of Indapamide and Perindopril Erbumine in Bulk and Tablet Dosage Form

INTRODUCTION: CHROMATOGRAPHY: The word chromatography is derived from the Greek letters chromos meaning color and the graph means color writing. The initial use of the terms is attributed to T Swett. It can be defined as “a separation process that is achieved by distribution of substance between two phases that is stationary phase and mobile phase. IMPORTANCE OF CHROMATOGRAPHY: Chromatography is one of the most powerful and versatile analytical techniques available to the modern chemist. Its power arises from its capacity to determine quantitatively many individual components present in a mixture in a single one analytical run. Its versatility comes from its capacity to handle wide variety of samples that may be gaseous, liquid or solid in nature. The sample can range in complexity from a single substance to a multi component mixture containing widely different chemical species. Another aspect of versatility is that the analysis can be carried out on a very costly complex instrument and on the other hand on a simple inexpensive thin layer plate. AIM: The aim of the work is to develop a precise, accurate, simple and reliable, less time consuming validated RP-PLC method for Indapamide and Perindopril erbumine in bulk and tablet dosage form. OBJECTIVE: 1. To develop new, simple, sensitive, accurate and economical analytical method for the simultaneous estimation of Indapamide and Perindopril erbumine. 2. To validate the proposed method in accordance with ICH guidelines for the intended analytical application. 3. To apply the proposed method for analysis of these drugs in their combined dosage form. SUMMARY: System suitability parameters were determined. The number of theoretical plates per column for Indapamide and Perindopril erbumine was found to be 6004 and 2831 respectively. The symmetry factor or tailing factor was found to be 1.3887 and 1.750 for Indapamide and Perindopril erbumine. The resolution of the method was calculated and was found to be 11.020. Specificity of the method was determined. The chromatogram of Indapamide and Perindopril erbumine were analyzed and there is no interference from diluents, excipients and impurities with peaks of Indapamide and Perindopril erbumine. Linearity of the drugs response was found to be in the concentration range of 2-12μg/ml for Indapamide and 5-30 μg/ml for Perindopril erbumine. The correlation coefficient and percentage curve fitting for Indapamide and Perindopril erbumine was found to be 0.999, 0.999 and 99.9%, 99.9% respectively which are well in the acceptance criteria limits. Precision of the system and method was determined. The %RSD values of retention time and Peak area for five injections of Indapamide and Perindopril erbumine were found to be 0.09, 0.48 and 0.0, 0.05 respectively which were well within acceptance criteria limit for system precision. The %RSD values for Retention time and Peak area for five injections of Indapamide and Perindopril erbumine were found to be 0.10, 0.06 and 0.59, 0.24 respectively, which were well within acceptance criteria for method precision. Hence the proposed method was found to provide high degree of precision and reproducibility. Accuracy was determined through recovery studies of Indapamide and Perindopril erbumine. The mean percentage recovery for Indapamide and Perindopril erbumine was found to be between 98.48- 99.90 and 99.89-99.96 respectively, which were well within the acceptance criteria and hence the method was found to be accurate, indicating no interference of the drugs with each other or with the excipients present in the formulation. CONCLUSION: A RP-HPLC method was developed and validated successfully for the estimation of Indapamide and Perindopril erbumine in bulk and tablet dosage formulation. The methods were found to be accurate, precise, linear, specific and reproducible for the simultaneous determination of Indapamide and Perindopril erbumine in bulk and tablet dosage form (tablets). Hence these methods can be used for simultaneous estimation of Indapamide and Perindopril erbumine in routine table