A Stability Indicating RP-HPLC Method Development for Simultaneous Estimation of Alogliptin, Pioglitazone, and Metformin in Finished Pharmaceutical Formulations

Abstract

Alogliptin, dipeptidyl peptidase-4 (DPP-4) inhibitor, Pioglitazone, thiazolidinediones (TZDs) and Metformin, biguanides are antidiabetic drugs that usually used in the management of type 2 diabetes that can be used solely or as combinations. In this article, a selective, simple, economical, precise, and stability-indicating RP-HPLC method has been developed and validated for assessing Alogliptin, Pioglitazone, and Metformin inside the bulk drug and tablet pharmaceutical dosage form. The mobile phase that used to separate the drug was consists of acetonitrile: buffer (potassium dihydrogen phosphate), (30 : 70 v/v) on an ACE C18 ñ (250 mm × 4.6 mm), 5 µm column at a flow rate of 1.0 mL/min at 25 O C and detection was at 230 nm. The linearity of the detector was established in concentrations ranging from 20-250 ppm; the regression coefficient was 0.9998. The ICH guidelines were followed to evaluate stability, where the API is stressed by acid, base, neutral, oxidation, and sunlight. Several parameters were used for validation, including linearity, precision, accuracy, the limit of detection, and limit of quantification. The results were fulfilling expectations based on ICH guidelines. Robustness of the method was verified in terms of changes in pH of the mobile phase, detector wavelength, mobile phase composition, and temperature. Also, the method results in low relative standard deviation and high recovery value, that ensure the convenience applicability of the method for routine analysis of tablet containing Alogliptin, Pioglitazone, and Metformin.

Separation of N-Methylhydroxamic Fatty Acids Based on Ketapang Seed Oil using High Performance Liquid Chromatography

“…The HPLC analytical method presents a simple, specific, accurate, and precise quantitative method (Ahmad, et al, 2022). Additionally, it is a beneficial analytical method for analyzing single or combined compounds (Habash, et al, 2020). The results of the chromatogram separation of N-MFHAs at optimum conditions can show that N-MFHAs consists of four main compounds that can be seen according to the four peaks formed on the chromatogram.…”

Coupling of NIR Spectroscopy and Chemometrics for the Quantification of Dexamethasone in Pharmaceutical Formulations

“…Analytical chemistry plays a key role in tackling the problem of counterfeit pharmaceutical formulations, as it allows the implementation of strategies that permit the recognition of uncompliant drugs. Over the years, various analytical techniques have been refined for this purpose; in particular, liquid chromatography strategies are commonly exploited to achieve this goal [ 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 ]. Although efficient, they have a number of disadvantages linked to the fact that they are destructive, require complex sample pretreatment prior to the analysis, and are time-consuming.…”

Evaluation of Naproxen and Esomeprazole in Bulk and Pharmaceutical Tablets Dosage Form by RP-Chromatography

“…ESZL, the S-isomer of omeprazole, is often more effective than other proton pump inhibitors currently available due to its favorable pharmacokinetic profile [3]. Several techniques have been used to estimate ESZL, including UV and RP-HPLC techniques [4][5][6][7][8][9][10][11][12][13][14][15]. Naproxen (NPXN) (Figure 1B), a well-known non-steroidal anti-inflammatory drug (NSAID), is used to reduce pain and fever associated with various illnesses.…”