Keen interest in the Development and Validation new Analytical Methods on sophisticated Instruments like UV – Visible Spectroscopy, High performance Liquid
Chromatography (HPLC), High performance thin layer chromatography (HPTLC) etc., Forced Degradation studies and Impurity Profiling
64
Scopus Publications
Scopus Publications
Planer chromatographic method development and validation of Tadalafil and Mirabegron using fractional factorial design approach Ghanshyam B Paladiya, Jinal Tandel, Heta Kachhiya, Usmangani Chhalotiya, Dimal Shah, Devang Tandel Journal of Chromatographic Science, 2026 The present research focuses on developing a high-performance thin-layer chromatographic (HPTLC) method using a design of experiment approach for simultaneously estimating Tadalafil and Mirabegron. Chromatographic separation was achieved on aluminum plates precoated with silica gel 60 F254 using an optimized mobile phase of MeOH: ACN: n-Butanol: TEA (6:2:2:0.1%v/v/v/v). A fractional factorial design was applied for the robustness study and the independent variables selected were chamber saturation time (A), wavelength (B), mobile phase composition (C) and solvent front (D). It was statistically revealed that the volume of MeOH affected the Rf of both drugs resulting in stricter control of MeOH volume compared to the other three variables. Rf for Tadalafil and Mirabegron was 0.75 and 0.45 at 242 nm. Calibration plots were linear for Tadalafil (100–300 ng/band) and Mirabegron (500–1500 ng/band), with recovery rates of 98.15%–100.34% and 98.46%–102.14%, respectively. The method was validated per ICH Q2(R1) guidelines, demonstrating linearity, precision, accuracy and selectivity, with %RSD values below 2% for both drugs. This HPTLC method is simple, accurate, reproducible and suitable for routine quality control of pharmaceutical formulations.
Development of stability indicating densitometric method for estimation of tegoprazan used in the treatment of gastroesophageal reflux disease Mitalben Parmar, Dimal Shah, Usmangani Chhalotiya Journal of Research in Pharmacy, 2026 Novel drug Tegoprazan has been introduced for the treatment of gastro-esophageal reflux disease. Accurate and precise thin layer chromatographic method has been developed and validated for estimation of tegoprazan. Silica gel G 60 F254 (20cm×20cm) coated aluminium backed plates were used as stationary phase and mixture of Toluene: Methanol (7.5: 2.5 v/v) was used as mobile phase. The compact band (Rf values 0.53 ± 0.1) was obtained for Tegoprazan. The method was found to be linear in the concentration range of 100 -700 ng/band with a linear regression equation showing linear relationship with R2 =0.9944. The method was validated as per ICH Q2 (R2) guidelines Forced degradation studies were carried out to assess molecule’s intrinsic stability, using acid and base hydrolysis, oxidative stress and photolytic degradation. Forced degradation study revealed that Tegoprazan was highly susceptible to acid hydrolysis. Greenness assessment for develop method was conducted using AGREE and White analytical chemistry. The evaluation confirmed environmentally friendly nature of developed method.
Computational discovery of uterotonic agents: Molecular docking and dynamic simulations of Caesalpinia bonduc phytoconstituents Jinal Tandel, Usmangani Chhalotiya, Heta Kachhiya, Ashish Patel, Parth Thakor, Jignesh Prajapati, Dweipayan Goswami Journal of Research in Pharmacy, 2025 Molecular modeling is widely applied to study the interaction and binding affinity of biological activity ofprotein and peptide. Molecular dynamics simulation can provide valuable information in deciphering functionalmechanisms of protein and other biomolecules, Caesalpinia bonduc (L) Roxb contains compounds that bind with estrogenreceptors, PGs receptors, Oxytocin receptors, Alpha-adrenergic receptors, etc. which are found on the surface ofmyometrial cells that affect contractility. The present study focuses on understanding the molecular mechanism ofbioactive compounds of Caesalpinia bonduc (L) Roxb for uterine contraction. The molecular docking of compounds thatare present in Caesalpinia bonduc (L) Roxb named α caesalpin, β caesalpin, ε caesalpin, caesalpin F, and Bonducellin wereperformed against 1FDS, 3S79, 1E3G, 3ERT targets. Molecular docking and dynamic simulation studies were establishedby applying Glide precision mode and Maestro respectively. The Molecular dynamic (MD) simulation was performed toanalyse the stability and interactions of the bioactive compounds from Caesalpinia bonduc (L) Roxb leaf extract. Dockinganalysis for active biomarkers of Caesalpinia bonduc (L) Roxb with target proteins revealed compound binding towardsselected proteins and activity against uterus contraction. Bonducellin exhibits the highest binding scores among allcompounds, the remaining α caesalpin, ε caesalpin, β caesalpin, and caesalpin F, were also found to have prominentbinding towards selected proteins. This stabilization is achieved through strong and stable interactions, as evidenced bythe MD simulation data. Among the compounds. The results suggest that Bonducellin and related compounds holdpromise as multi-target Uterotonic agents, with potential applications in managing labour and reducing postpartumhaemorrhage..
Accelerated Stability Indicating LC Method for Simultaneous Quantification of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate Gopal Valiya, Hetaben Kachhiya, Ruturaj Sutarsandhiya, Riddhi Patel, Jinal Tandel, Usmangani Chhalotiya, Dimal Shah Separation Science Plus, 2025 A combination of dapagliflozin propanediol monohydrate and bisoprolol fumarate was approved by a regulatory agency for the treatment of Type 2 diabetes mellitus in patients with hypertension. A simple reverse‐phase LC method was developed and validated for simultaneous quantification of dapagliflozin propanediol monohydrate and bisoprolol fumarate in bulk and marketed formulation. The optimized chromatographic condition includes Inertsil ODS 3 V (250 mm × 4.6 mm, 5 µm) as the stationary phase, gradient elution of mobile phase A containing 26 mM KH2PO4 containing 0.4 mL/L triethylamine (pH 4.2 adjusted with dilute orthophosphoric acid) and acetonitrile in ratio of 90:10 v/v and mobile phase B containing 26 mM KH2PO4 containing 0.4 mL/L triethylamine (pH 4.2 adjusted with dilute orthophosphoric acid) and acetonitrile in ratio of 25:75 v/v with flow rate of 1 mL/min. The analytical wavelength for detection of both drugs was 223 nm. The forced degradation study was also carried out to estimate the stability of drugs in bulk and formulation. The stress condition applied were acid, alkali, oxidative, thermal, and light. Dapagliflozin propanediol monohydrate was found to be stable and bisoprolol fumarate was degrading under oxidative and light conditions and remaining stable in other conditions applied. The proposed method was found to be linear in the concentration range of 2–24 µg/mL and 1–12 µg/mL with R2 value of 0.9998 and 0.9984 for dapagliflozin propanediol monohydrate and bisoprolol fumarate, respectively. The optimized method was validated as per ICH Q2 (R2) guidelines and was found to be selective, specific, precise, accurate, and robust for quantification of both drugs.
Stability indicating HPTLC–densitometric method for estimation of vonoprazan fumarate Mitalben S. Parmar, Dimal A. Shah, Usmangani K. Chhalotiya Drug Development and Industrial Pharmacy, 2025 OBJECTIVES High performance thin layer chromatography method was developed and validated for analysis of vonoprazan fumarate. An Alkaline forced degradation kinetic study was performed to find out probable rate of degradation of vonoprazan fumarate. MATERIAL AND METHODS Aluminum packed TLC plates precoated with silica gel 60F 254 were used as stationary phase and Methanol: Toluene: triethylamine (6: 4: 0.1 v/v/v) was used as mobile phase. The detection was carried out at 267 nm wavelength as absorbance mode. HPTLC/MS analysis study was performed to detect alkaline degradant. RESULTS A compact band (Rf value of 0.43 ± 0.1) was obtained for vonoprazan fumarate. Regression analysis shows a good linear relationship (R2 = 0.9996) between peak area and concentration in the range 200-1200 ng/band. The accuracy determined by standard addition method for vonoprazan fumarate and percentage recovery was found to be 99.72% - 101.74%. Forced degradation stability study was performed under different stress conditions including hydrolytic, oxidative, thermal and photolytic. Degradation was observed under alkaline condition and it was found to follow first order degradation kinetic. The possible structure of base degradants was also determined using HPTLC-MS analysis. The method was successfully applied for the estimation of drug in synthetic mixture. CONCLUSION A New, Simple, precise and accurate method has been developed and validated for the quantification of vonoprazan fumarate. Forced degradation studies were performed. The method can be used for quality control and stability sample evaluation of vonoprazan fumarate.
Stability indicating HPTLC method for the estimation of ticagrelor in bulk and in pharmaceutical dosage form Indian Drugs, 2016
Simultaneous estimation of moxonidine and amlodipine besylate in their pharmaceutical dosage form by stability-indicating LC method Indian Drugs, 2016
Development of HPTLC method for the estimation of ondansetron and ranitidine in combined dosage form Indian Drugs, 2015
Simultaneous Quantification of Metolazone and Ramiprilin Their Combined Dosage Form by First Order Derivative Spectroscopic Method Turkish Journal of Pharmaceutical Sciences, 2015
Development and validation of a liquid chromatographic method for estimation of dicyclomine hydrochloride, mefenamic acid and paracetamol in tablets Indian Journal of Pharmaceutical Sciences, 2014
Quantification of clioquinol in bulk and pharmaceutical dosage forms by stability indicating LC method Turkish Journal of Pharmaceutical Sciences, 2014
Development of LC method for estimation of diethyl carbamazine citrate and chlorpheniramine maleate in combined dosage form Turkish Journal of Pharmaceutical Sciences, 2014
Natural polysaccharides as film former: A feasibility study for development of rapid dissolving films of ondansetron hydrochloride International Journal of Pharmacy and Pharmaceutical Sciences, 2012
Liquid chromatographic method for the estimation of donepezil hydrochloride in a pharmaceutical formulation International Journal of Chemtech Research, 2011