Volume : 13, Issue : 08, August – 2026
Title:
DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF LINAGLIPTIN AND DAPAGLIFLOZIN IN BIORELEVANT DISSOLUTION MEDIA: MICELLAR PROTECTION OF DAPAGLIFLOZIN AND DISSOLUTION DISCRIMINATORY ANALYSIS
Authors :
Battula Sammaiah*, Dr. Ram Prasad
Abstract :
A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and fully validated for simultaneous quantification of linagliptin (LIN) and dapagliflozin (DAP) in the fixed-dose combination (FDC) tablet approved by the Drugs Controller General of India (DCGI) in November 2024. Chromatographic separation was achieved on an Inertsil ODS-3 column (250 × 4.6 mm, 5 μm) with an isocratic mobile phase of acetonitrile: 0.1% v/v ortho-phosphoric acid (pH 3.0), 45:55 (v/v), at 1.0 mL min⁻¹, 30 °C, and 224 nm detection; total run time was 10 min. Working concentrations of 2.78 μg mL⁻¹ (LIN) and 5.56 μg mL⁻¹ (DAP) corresponded to complete label-dose release into the USP default 900 mL dissolution vessel. Validation was conducted in four matrices — diluent, fasted simulated gastric fluid (FaSSGF), fasted simulated intestinal fluid version 2 (FaSSIF-V2), and fed simulated intestinal fluid version 2 (FeSSIF-V2) — against the full ICH Q2(R1) and Q2(R2) parameter set. All criteria were satisfied: linearity r² ≥ 0.9999, accuracy 99.27–99.90% (%RSD ≤ 1.05%), precision %RSD ≤ 0.83%, and limit of quantitation ≤ 0.212 μg mL⁻¹. Forced degradation under six ICH Q1A(R2)/Q1B conditions was conducted in diluent and repeated inside FaSSIF-V2 and FeSSIF-V2, revealing that bile-salt micelles attenuate DAP degradation by 1.8–3.5 percentage points under acid and oxidative stress — consistent with pseudo-phase kinetic shielding — while linagliptin (logP 0.4) showed no appreciable micellar protection. Biorelevant dissolution in six media showed DAP release of 85.84% at 15 min in FeSSIF-V2 versus 67–73% in fasted and compendial media, with pairwise f₂ < 50 for fed-versus-fasted comparisons. Tablet assay returned 99.997% (LIN) and 99.893% (DAP) of label claim, %RSD < 0.19%. The method is the first to couple full biorelevant-matrix ICH Q2 validation with in-medium forced degradation for this drug pair.
Keywords: Linagliptin; Dapagliflozin; RP-HPLC; stability-indicating; biorelevant dissolution; FaSSIF-V2; FeSSIF-V2; ICH Q2; fixed-dose combination; micellar solubilization; type 2 diabetes mellitus.
Cite This Article:
Please cite this article in press Battula Sammaiah et al., Development And Validation Of A Stability-Indicating Reversed-Phase Hplc Method For Simultaneous Quantification Of Linagliptin And Dapagliflozin In Biorelevant Dissolution Media: Micellar Protection Of Dapagliflozin And Dissolution Discriminatory Analysis. Indo Am. J. P. Sci, 2026; 13(08).
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Volume : 13, Issue : 08, August – 2026
Title:
EVALUATION OF ANTIHYPERLIPIDEMIC ACTIVITY OF SAPINDUS EMARGINATUS IN RATS
Authors :
Chinthala Jamima*, Dr.R.narasimha Rao, Dr.N. Raghunandhan
Abstract :
Obesity and hyperlipidemia have become major disorders predominantly causing prevailing cardiovascular diseases and ultimately death. The prolonged use of anti-obesity drugs and statins for reducing obesity and blood lipid levels is leading toward adverse effects of kidneys and muscles, specifically rhabdomyolysis. The objective of this study is to evaluate potential of seeds of Sapindus emarginatus against hyperlipidemia. In this model of Hyperlipidemia, 30 adult male wistar rats (200-250gms) were evenly divided into 5 groups in both groups. Group-1 and Group-2 served as untreated and model controls respectively, while Group-3, 4 and 5 were the treatments groups which were simultaneously treated with standard, 100 and 200 mg/kg extract respectively along with High Fat Diet. On last day, blood samples for biochemical parameters, were obtained under inhaled diether anaesthesia. The outcomes of this study were expressed as mean standard error and data were evaluated by using analysis of variance followed by multiple comparisons. Oral administration of 100 mg/ kg and 200mg/kg body weight of Methanolic extract residual fraction of Moringa oleifera. Leaves exhibited a significant reduction (P < 0.01) in serum lipid parameters such as triglycerides, total cholesterol, low density lipoprotein (LDL), very LDL and increase in high density lipoprotein in hyperlipidemic rats when compared with hyperlipidemic control in both models. Our results demonstrated that Methanolic extract fraction of Sesbania grandiflora. Possessed significant antihyperlipidemic activity.
Keywords: Sesbania grandiflora, Cholesterol, LDL, triglycerides and antihyperlipidemic activity.
Cite This Article:
Please cite this article in press Chinthala Jamimaet al., Evaluation of Antihyperlipidemic activity of Sapindus Emarginatus in rats,, Indo Am. J. P. Sci, 2026; 13(08).
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