Simultaneous Estimation Of Sitagliptin, Metformin Hydrochloride, Glimepiride In Bulk And Their Pharmaceutical Dosage Form By RP-HPLC Method

Abstract

Hyperglycemia means an increased blood glucose level, also known as Diabetes Mellitus. Every year, the number of patients with this disease has been increase tremendously. A person has to administer medicine to manage the symptoms of diabetes. Therefore, the pharmaceutical dosage form to be evaluated for patient safety and efficacy. The method was developed and validated as per the ICH guideline for the simultaneous estimation of three drugs in a combined dosage form as a tablet. Sitagliptin, Metformin Hydrochloride, and Glimepiride drugs were analysed by using the RP-HPLC technique at 230 nm. During analysis, the linearity of these drugs was 12.5-62.5, 250-1250, and 0.5-2.5 µg/ml for Sitagliptin, Metformin Hydrochloride, and Glimepiride, respectively. Accuracy was obtained between 97 to 99% for all drugs. The proposed method was employed in a pharmaceutical solid dosage form for assay values found between 98 to 99.5%, respectively. Several other parameters, including LOD, LOQ, Precision, Specificity and Robustness, were also applied, and the method was considered sensitive, precise, specific and robust, which was the prime objective of method development and validation. The proposed method has value for quantitative and qualitative estimation in any pharmaceutical dosage form. Furthermore, this technique would become a basis for bioanalytical study and the impurity profile of these substances.